EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions

Not Applicable

Completed

Conditions: Coronary Artery Disease (CAD)
Chronic Total Occlusion (CTO)

Registration Number: NCT01435031

Lead Sponsor: Abbott Medical Devices

Brief Summary: A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 250

Inclusion Criteria

Subject is ≥ 18 years of age at the time of consent.
Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization.
Subject is eligible and consents to undergo percutaneous coronary intervention (PCI procedure).
Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG).
Subject is willing and able to sign an informed consent form (ICF) approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up.
Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before enrollment and effective birth control must be used up to 1 year following the index procedure.

Angiographic Inclusion Criteria

A maximum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram:
- High-grade native coronary stenosis
- TIMI 0 or 1 antegrade flow
Occluded segment suitable for placement of coronary stents:
- Segment without severe tortuosity (angulation ≥ 45º)
- Segment not located in an excessively distal location

General Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions are present:

Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, stainless steel, or everolimus
Evidence of acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q-wave or non-Q-wave MI having creatine kinase (CK) enzymes 2 × the upper limit of normal (ULN) with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) above the Institution's ULN, or troponin (I or T) above the Institution's ULN)
Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel
Planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with any alternative drug eluting stent (DES) (e.g., CYPHER Sirolimus-Eluting stent, TAXUS Paclitaxel-Eluting stent or Endeavor Zotarolimus-Eluting Endeavor stent)
Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin)
Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement (including, but not limited to directional or rotational coronary atherectomy, excimer laser, thrombectomy, etc.). Note: Use of alternative technologies to conventional guide wires that are approved by the United States Food and Drug Administration for CTO revascularization (e.g., Asahi Tornus and Corsair catheters, IntraLuminal Therapeutics Safe Cross guide wire, Flowcardia CROSSER system) is permitted and will be collected in the case report form.
Patients with history of clinically significant abnormal laboratory findings including:
- Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks, or
- Thrombocytopenia (<100,000 platelets/mm3), or
- Aspartate Transaminase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase, or bilirubin > 1.5 × ULN, or
- Serum creatinine > 1.5 mg/dL
Patients with evidence of ongoing or active clinical instability including the following:
- Sustained systolic blood pressure < 100 mmHg or cardiogenic shock
- Acute pulmonary edema or severe congestive heart failure
- Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
- Suspected dissecting aortic aneurysm
- Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
Target lesion involves a bifurcation including a diseased side branch ≥2.25 mm in diameter that would require treatment
Target vessel with a patent bypass graft from prior coronary bypass surgery
Proximal coronary stenting of target lesion
History of stroke or transient ischemic attack within the prior 6 months
Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
History of bleeding diathesis or coagulopathy or refusal of blood transfusions
Patients with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study.
Known previous medical condition yielding expected survival less than 1 year.
Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements.
Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS), or other coronary artery imaging procedures

Angiographic Exclusion Criteria

Candidates will be excluded from study if any of the following conditions are met:

Occlusion involves segment within previous stent
Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:
- It has been at least 9 months since the previous stenting.
- That target lesion is at least 15 mm away from the previously placed stent.
- The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.
The target vessel has other lesions proximal to the total occlusion identified with greater than 40% diameter stenosis based on visual estimate or on-line quantitative coronary angiography (QCA). However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (ie, tandem lesions) are acceptable.

Exclusion Criteria (Non-target Lesion):

The lesion is located in a native vessel distal to anastomosis with a graft.
The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
The vessel has evidence of thrombus.
The vessel is excessively tortuous.
The lesion has any of the following characteristics:
- Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA).
- Involves a side branch > 2.0 mm in diameter.
- Is at or distal to a > 45º bend in the vessel.
- Is moderately to severely calcified.
- TIMI flow 0 or 1.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on ARC MI (component 2)
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Successful recanalization of the CTO defined as: 1. Confirmation of placement of the guide wire in the distal true lumen (component 1) 2. Absence of in-hospital MACE, based on protocol MI (component 2)
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)	1 year	The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)	1 year	The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.
Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	1. Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and; 2. Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and; 3. Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and; 4. Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure

Secondary Outcome Measures

Name	Time	Method
Minimum Lumen Diameter (MLD): Pre-procedure	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.
Minimum Lumen Diameter (MLD): Post-procedure	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory.
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. TIMI Classification: TIMI 0 No perfusion. TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run. TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel. TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Percentage of Participants With Device Success	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Achievement of \<50% diameter stenosis within the target lesion segment using assigned study device
Percentage of Participants With Procedure Success	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Device success and absence of in-hospital MACE. Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves). Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.
Percentage of Participants With Procedural Success With Antegrade Crossing	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Knuckle Wire	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Reverse CART	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Kissing Wire Technique	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Sub Intimal Technique	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Percentage of Participants With Procedural Success With Multiple Crossing Techniques	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Resource Utilization: Procedural Time	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Number of Participants Experiencing Cardiac Death	4 years	TLF component. Cardiac death was defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded
Resource Utilization: Fluoroscopic Time	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Resource Utilization: Contrast Volume	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Clinically Significant Perforation	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes	Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy
Number of Participants With Major Adverse Cardiac Events (MACE)	4 years	Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants Experiencing Death	4 years	MACE Component; per protocol. Death is divided into 2 categories: Cardiac death is defined as death due to any of the following: 1. Acute MI 2. Cardiac perforation/pericardial tamponade 3. Arrhythmia or conduction abnormality 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure 5. Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery 6. Any death in which a cardiac cause cannot be excluded. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)	4 years	MACE Component; Myocardial Infarction (per ARC definition) * Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal * Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Target Vessel-related MI	4 years	TLF Component; per ARC Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Lesion Revascularization (TLR)	4 years	Repeat PCI or CABG to the target lesion/site.
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)	4 years	TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)	1 year	TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target lesion with diameter stenosis \>= 70% by QCA without either angina or a positive functional study.
Number of Participants With All Target Vessel Revascularization (TVR)	4 years	Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis \>= 50% by QCA, or revascularization of a target vessel with diameter stenosis \>= 70% by QCA without either angina or a positive functional study
Number of Participants With Target Vessel Failure (TVF)	4 years	Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol. Target vessel failure will be reported when ANY of the following events occur: * Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel. * Cardiac death not clearly due to a non-target vessel endpoint. * Target vessel revascularization is determined.
Number of Participants With Target Lesion Failure (TLF)	4 years	Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Number of Participants With Stent Thrombosis	4 years	Academic Research Consortium (ARC) criteria. Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy). Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Occurrence of Stent Fracture at Target Lesion	4 years	Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.