ABSORB III Randomized Controlled Trial (RCT)

Not Applicable

Completed

Conditions: Coronary Stenosis
Coronary Artery Disease
Coronary Disease
Coronary Artery Stenosis

Interventions: Device: Absorb BVS
Device: XIENCE

Registration Number: NCT01751906

Lead Sponsor: Abbott Medical Devices

Brief Summary: The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

Detailed Description: ABSORB III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

2. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2008

Inclusion Criteria

Subject must be at least 18 years of age.
Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

One or two de novo target lesions:
1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and < 100% with a TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.
1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

General

Exclusion Criteria

Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:
1. Subject requires coumadin or any other agent for chronic oral anticoagulation.
2. Subject is likely to become hemodynamically unstable due to their arrhythmia.
3. Subject has poor survival prognosis due to their arrhythmia.
Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure
Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
At the time of screening, the subject has a malignancy that is not in remission.
Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.
Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
1. Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.
2. TIMI Grade-3 flow (per visual estimation).
3. No angiographic complications (e.g. distal embolization, side branch closure).
4. No dissections NHLBI grade D-F.
5. No chest pain lasting > 5 minutes.
6. No ST depression or elevation lasting > 5 minutes.
Lesion is located in left main.
Aorto-ostial RCA lesion (within 3 mm of the ostium).
Lesion located within 3 mm of the origin of the LAD or LCX.
Lesion involving a bifurcation with a:
1. side branch ≥ 2 mm in diameter, or
2. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
3. side branch requiring dilatation
Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
Lesion or vessel involves a myocardial bridge.
Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorb BVS	Absorb BVS	Subjects receiving Absorb BVS
XIENCE	XIENCE	Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition

Primary Outcome Measures

Name	Time	Method
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	1 year	TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Powered Secondary Endpoint: Angina	1 year	Angina is defined as the first adverse event resulting in the site diagnosis of angina.
Number of Participants With All Myocardial Infarction (MI)	0 to 5 years	* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Number of Participants With All Revascularization	0 to 5 years	All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Number of Death/All MI/All Revascularization (DMR)	0 to 5 years	DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)	1 year	This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
Number of Participants With All Target Lesion Revascularization (TLR)	0 to 5 years	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Acute Success- Device Success (Lesion Level Analysis)	On day 0 (the day of procedure)	Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)	0 to 5 years	TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With Powered Secondary Endpoint: All Revascularization	1 year	This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
Acute Success: Procedural Success (Subject Level Analysis)	On day 0 (the day of procedure)	Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Number of Death (Cardiac, Vascular, Non-cardiovascular)	0 to 5 years	DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Death/All MI	0 to 5 years	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)	366 to 393 Days	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Number of Participants With Cumulative Stent/Scaffold Thrombosis	0 to 1853 Days	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal	3 Years	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Number of Cardiac Death/All MI	0 to 5 years	All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	0 to 5 years	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)	31 to 365 Days	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Pre-Procedure Minimum Lumen Diameter (MLD)	< or = 1 day	Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
Post-Procedure In-Segment Minimum Lumen Diameter (MLD)	≤ 7 days post index procedure	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Post-Procedure In-Device Acute Gain	≤ 7 days post index procedure	The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)	3 Years	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)	0 to 5 years	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants With Target Vessel Failure (TVF)	0 to 5 years	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)	0 to 30 Days	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Post-Procedure In-Device Minimum Lumen Diameter (MLD)	≤ 7 days post index procedure	Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)	From Post procedure to 3 Years	* Mean lumen area measured after nitrate infusions, superiority test, \~300 pooled subjects. * Pooled IVUS subjects (\~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)	≤ 1 Day	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Pre-Procedure Percent Diameter Stenosis (%DS)	< or = 1 day	Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Post-Procedure In-Segment Percent Diameter Stenosis (%DS)	≤ 7 days post index procedure	Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Post-Procedure In-Device Percent Diameter Stenosis (%DS)	≤ 7 days post index procedure	Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area	3 Years	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Number of Participants With Subacute Stent/Scaffold Thrombosis	>1 to 30 Days	Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area	3 Years	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts	3 Years	All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

Trial Locations

Locations (189): Scripps Memorial Hospital
🇺🇸
La Jolla, California, United States
Chandler Regional Medical Center
🇺🇸
Gilbert, Arizona, United States
Banner Heart Hospital
🇺🇸
Mesa, Arizona, United States
Good Samaritan Hospital
🇺🇸
Los Angeles, California, United States
Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
Brandon Regional Hospital
🇺🇸
Brandon, Florida, United States
Wellstar Kennestone Hospital
🇺🇸
Marietta, Georgia, United States
St. John's Hospital
🇺🇸
Springfield, Illinois, United States
Christiana Care Health Services
🇺🇸
Newark, Delaware, United States
Bay County Health Systems
🇺🇸
Panama City, Florida, United States
Scripps Green Hospital
🇺🇸
La Jolla, California, United States
Torrance Memorial Medical Center
🇺🇸
Torrance, California, United States
Washington Hospital
🇺🇸
Fremont, California, United States
John Muir Medical Center - Concord Campus
🇺🇸
Concord, California, United States
Medical Center of the Rockies
🇺🇸
Fort Collins, Colorado, United States
Morton Plant Hospital
🇺🇸
Clearwater, Florida, United States
UCH-Memorial Health Systems
🇺🇸
Colorado Springs, Colorado, United States
Elkhart General Healthcare
🇺🇸
Elkhart, Indiana, United States
Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
Palm Beach Gardens Medical Center
🇺🇸
Palm Beach Gardens, Florida, United States
Borgess Medical Center
🇺🇸
Kalamazoo, Michigan, United States
Northeast Georgia Medical Center
🇺🇸
Gainesville, Georgia, United States
MediQuest Research Group Inc at Munroe Regional Medical Center
🇺🇸
Ocala, Florida, United States
Bay Regional Medical Center
🇺🇸
Bay City, Michigan, United States
Memorial Regional Hospital
🇺🇸
Hollywood, Florida, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Baptist Hospital
🇺🇸
Pensacola, Florida, United States
Northern Michigan Hospital
🇺🇸
Petoskey, Michigan, United States
Our Lady of Lourdes Medical Center
🇺🇸
Haddon Heights, New Jersey, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
North Memorial Medical Center
🇺🇸
Robbinsdale, Minnesota, United States
Barnes Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
North Mississippi Medical Center Cardiology Associates Research, LLC
🇺🇸
Tupelo, Mississippi, United States
Oakwood Hospital and Medical Center
🇺🇸
Dearborn, Michigan, United States
St. Joseph's Regional Medical Center
🇺🇸
Paterson, New Jersey, United States
PeaceHealth Sacred Heart Medical Center
🇺🇸
Springfield, Oregon, United States
New York Presbyterian Hospital-Cornell University
🇺🇸
New York, New York, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
The Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
The Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Hillcrest Medical Center
🇺🇸
Tulsa, Oklahoma, United States
Cleveland Cln Fairview Hospital
🇺🇸
Fairview Park, Ohio, United States
Nebraska Heart Hospital
🇺🇸
Lincoln, Nebraska, United States
St. Joseph's Hospital Health Center
🇺🇸
Liverpool, New York, United States
Holy Spirit Hospital
🇺🇸
Camp Hill, Pennsylvania, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
AnMed Health
🇺🇸
Anderson, South Carolina, United States
St. Mary Medical Center
🇺🇸
Langhorne, Pennsylvania, United States
Genesis-Good Samaritan Hospital
🇺🇸
Zanesville, Ohio, United States
Rex Hospital
🇺🇸
Raleigh, North Carolina, United States
Englewood Hospital and Medical Center
🇺🇸
Englewood, New Jersey, United States
Sparrow Hospital
🇺🇸
Lansing, Michigan, United States
Boone Hospital Center
🇺🇸
Columbia, Missouri, United States
Mercy St. Vincent's Medical Center
🇺🇸
Toledo, Ohio, United States
Kettering Medical Center
🇺🇸
Kettering, Ohio, United States
EMH Healthcare
🇺🇸
Elyria, Ohio, United States
Penn Presbyterian Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Trinity Mother Frances Hospital Regional Healthcare Center
🇺🇸
Tyler, Texas, United States
East Texas Medical Center
🇺🇸
Tyler, Texas, United States
UPMC Hamot
🇺🇸
Erie, Pennsylvania, United States
Doylestown Hospital
🇺🇸
Doylestown, Pennsylvania, United States
Turkey Creek Medical Center
🇺🇸
Knoxville, Tennessee, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
UPMC Shadyside Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Greenville Memorial Hospital of the Greenville Health System
🇺🇸
Greenville, South Carolina, United States
St. Joseph Medical Center
🇺🇸
Wyomissing, Pennsylvania, United States
Providence Regional Medical Center Everett
🇺🇸
Everett, Washington, United States
Carilion Roanoke Memorial Hospital
🇺🇸
Roanoke, Virginia, United States
St. Joseph Hospital
🇺🇸
Bellingham, Washington, United States
Pinnacle Health at Harrisburg Hospital
🇺🇸
Wormleysburg, Pennsylvania, United States
Sisters of Charity Providence Hospital
🇺🇸
Columbia, South Carolina, United States
Wellmont Holston Valley Medical Center
🇺🇸
Kingsport, Tennessee, United States
Fletcher Allen Health Care
🇺🇸
Burlington, Vermont, United States
Northwest Texas Healthcare System
🇺🇸
Amarillo, Texas, United States
Winchester Medical Center
🇺🇸
Winchester, Virginia, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
The Methodist Hospital Research Institute
🇺🇸
Houston, Texas, United States
University of Miami Hospital
🇺🇸
Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸
Miami, Florida, United States
St. Vincent Heart Center of Indiana
🇺🇸
Indianapolis, Indiana, United States
Thomas Hospital
🇺🇸
Fairhope, Alabama, United States
Baptist Medical Center South
🇺🇸
Montgomery, Alabama, United States
Scottsdale Healthcare
🇺🇸
Scottsdale, Arizona, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Sutter Central Valley Hospitals dba Memorial Medical Center
🇺🇸
Modesto, California, United States
Santa Barbara Cottage Hospital
🇺🇸
Santa Barbara, California, United States
Little Company Of Mary Hospital
🇺🇸
Torrance, California, United States
University of Florida UF Health
🇺🇸
Jacksonville, Florida, United States
Baptist Medical Center - Downtown
🇺🇸
Jacksonville, Florida, United States
Tallahassee Memorial Hospital
🇺🇸
Tallahassee, Florida, United States
Saint Joseph's Hospital of Atlanta
🇺🇸
Atlanta, Georgia, United States
Saint Francis Medical Center
🇺🇸
Peoria, Illinois, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Indiana University Health Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
Franciscan St. Francis Health
🇺🇸
Indianapolis, Indiana, United States
Genesis Medical Center
🇺🇸
Davenport, Iowa, United States
Mercy Medical
🇺🇸
West Des Moines, Iowa, United States
Eastern Maine Medical Center
🇺🇸
Bangor, Maine, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
MedStar Washington Hospital Center
🇺🇸
Hyattsville, Maryland, United States
Union Memorial Hospital
🇺🇸
Hyattsville, Maryland, United States
Peninsula Regional Medical Center
🇺🇸
Salisbury, Maryland, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Boston University Medical Center
🇺🇸
Boston, Massachusetts, United States
St. Elizabeth's Medical Center of Boston
🇺🇸
Brighton, Massachusetts, United States
UMass Memorial Medical Center
🇺🇸
Worcester, Massachusetts, United States
St. Joseph Mercy Hospital
🇺🇸
Ypsilanti, Michigan, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
Cooper University Hospital
🇺🇸
Haddon Heights, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸
Neptune, New Jersey, United States
Presbyterian Hospital
🇺🇸
Charlotte, North Carolina, United States
Long Island Jewish Medical Center
🇺🇸
Manhasset, New York, United States
Lennox Hill Hospital,
🇺🇸
New York, New York, United States
Rochester General Hospital
🇺🇸
Rochester, New York, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
WakeMed
🇺🇸
Raleigh, North Carolina, United States
Aultman Hospital
🇺🇸
Canton, Ohio, United States
University Hospitals of Cleveland
🇺🇸
Cleveland, Ohio, United States
UPMC Presbyterian
🇺🇸
Pittsburgh, Pennsylvania, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
University Hospital
🇺🇸
Cincinnati, Ohio, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Tri-Health Good Samaritan Hospital
🇺🇸
Cincinnati, Ohio, United States
Bethesda North Hospital
🇺🇸
Cincinnati, Ohio, United States
St. Francis Health System
🇺🇸
Greenville, South Carolina, United States
Memorial Hospital
🇺🇸
Chattanooga, Tennessee, United States
Sanford USD Medical Center
🇺🇸
Sioux Falls, South Dakota, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
🇺🇸
Dallas, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Mary Washington Hospital
🇺🇸
Fredericksburg, Virginia, United States
Royal Brisbane and Women's Hospital
🇦🇺
Herston, Queensland, Australia
St. Mary's Medical Center
🇺🇸
Huntington, West Virginia, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Methodist Texsan Hospital
🇺🇸
San Antonio, Texas, United States
Strong Memorial Hospital
🇺🇸
Rochester, New York, United States
The University of Kansas Hospital and Medical Center
🇺🇸
Kansas City, Kansas, United States
Banner Good Samaritan Medical Center
🇺🇸
Phoenix, Arizona, United States
Harper University Hospital
🇺🇸
Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
St. John Hospital & Medical Center
🇺🇸
Detroit, Michigan, United States
Integris Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Oklahoma Heart Hospital
🇺🇸
Oklahoma City, Oklahoma, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
The Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
St. Vincent's Hospital Melbourne
🇦🇺
Fitzroy, Victoria, Australia
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Mercy Hospital Springfield
🇺🇸
Springfield, Missouri, United States
St. Patrick Hospital
🇺🇸
Missoula, Montana, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Baptist Medical Center Princeton
🇺🇸
Birmingham, Alabama, United States
University of Alabama Hospital
🇺🇸
Birmingham, Alabama, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Florida Hospital Pepin Heart Institute
🇺🇸
Tampa, Florida, United States
St. Anthony's Medical Center
🇺🇸
Saint Louis, Missouri, United States
Aurora St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Morristown Medical Center
🇺🇸
Morristown, New Jersey, United States
Seton Medical Center Austin
🇺🇸
Austin, Texas, United States
Mercy General Hospital
🇺🇸
Sacramento, California, United States
UC Davis Medical Center
🇺🇸
Sacramento, California, United States
Sutter Medical Center
🇺🇸
Sacramento, California, United States
Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
Yale-New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Novant Health Forsyth Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Wake Forest University Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Washington Adventist Hospital
🇺🇸
Takoma Park, Maryland, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
University of Kentucky Medical Center
🇺🇸
Lexington, Kentucky, United States
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
St. Vincent's Medical Center
🇺🇸
Jacksonville, Florida, United States
Winthrop University Hospital
🇺🇸
Mineola, New York, United States
InterMountain Medical Center
🇺🇸
Murray, Utah, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States