ABSORB Clinical Investigation, Cohort B

Not Applicable

Completed

Conditions: Coronary Artery Disease
Coronary Restenosis
Coronary Disease

Interventions: Device: Bioabsorbable Everolimus Eluting Coronary Stent

Registration Number: NCT00856856

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.

Currently in development at Abbott Vascular. Not available for sale in the United States.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Absorb stent	Bioabsorbable Everolimus Eluting Coronary Stent	Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

Primary Outcome Measures

Name	Time	Method
Hierarchical Major Adverse Cardiac Event (MACE)	1 year	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days	180 days	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year	1 year	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up

Secondary Outcome Measures

Name	Time	Method
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years	2 years	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years	3 years	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years	2 years	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years	3 years	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years	5 years	In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Clinical Device Success (Per Lesion)	On day 0 (the day of procedure)	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Clinical Procedure Success (Per Patient)	On day 0 (the day of procedure)	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Hierarchical Target Vessel Failure (TVF)	5 years	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Hierarchical Major Adverse Cardiac Event (MACE)	5 years	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Cardiac Death	5 years	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
Myocardial Infarction	5 years	Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year	1 year	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years	2 years	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Persisting Dissection	5 years	Dissection at follow-up that was present post-procedure.
Volume Obstruction (VO)	3 year	Defined as scaffold intimal hyperplasia and calculated as 100\*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Ischemia Driven Target Lesion Revascularization (ID-TLR)	5 years	ID-TLR is defined as the revascularization at the target lesion associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Ischemia Driven Target Vessel Revascularization (ID-TVR)	5 years	ID-TVR is the revascularization in the target vessel associated with any of the following: * Positive functional ischemia study * Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days	180 days	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year	1 year	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days	180 days	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years	3 years	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Aneurysm	5 years	An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Late Incomplete Apposition	3 year	Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Scaffold Thrombosis	5 years	Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (\>1day ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion) * In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific ST /T changes and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years	5 years	Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
In-scaffold Percent Diameter Stenosis (%DS)	5 years	Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Persisting Incomplete Apposition	3 year	Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure. Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years	5 years	Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Vasomotion Analysis: In-scaffold Mean Luminal Diameter	5 years	Vasomotion function was assessed in reaction to nitrate administration.
In-scaffold Angiographic Binary Restenosis (ABR)	5 years	Percent of patients with a followup percent diameter stenosis of \>=50% per QCA.
Thrombus	5 years

Trial Locations

Locations (12): Onze-Lieve VrouweZiekenhuis
🇧🇪
Aalst, Belgium
Institut Hospitalier Jacques Cartier
🇫🇷
Massy, France
Monash Heart
🇦🇺
Melbourne, Australia
Skejby Sygehus
🇩🇰
Aarhus, Denmark
St. Vincent's Hospital
🇦🇺
Melbourne, Victoria, Australia
Jagiellonian University
🇵🇱
Krakow, Poland
Auckland City Hospital
🇳🇿
Auckland, New Zealand
Maasstad Ziekenhuis
🇳🇱
Rotterdam, Netherlands
Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands
Catharina ZH Eindhoven
🇳🇱
Eindhoven, Netherlands
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
Inselspital Bern, Kardiologie
🇨🇭
Bern, Switzerland