Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- 另有 13 项未显示
排除标准
- 未提供
研究组 & 干预措施
CTO Treatment
Subjects receiving at least 1 of the following for the treatment of CTO:
- XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
- HT PROGRESS and/or HT PILOT guide wires in recanalization
- MINI-TREK Coronary Dilatation Catheter in predilatation
干预措施: CTO Treatment Device (Device)
结局指标
主要结局
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
次要结局
- Minimum Lumen Diameter (MLD): Pre-procedure(Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes)
- Minimum Lumen Diameter (MLD): Post-procedure(Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes)
- 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)
- 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)
- Percentage of Participants With Device Success(Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes)
- Percentage of Participants With Procedure Success(Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Number of Participants With Major Adverse Cardiac Events (MACE)(4 years)
- Number of Participants Experiencing Death(4 years)
- Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)(4 years)
- Number of Participants With Target Vessel-related MI(4 years)
- Number of Participants With Target Lesion Revascularization (TLR)(4 years)
- Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)(4 years)
- Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)(1 year)
- Number of Participants With All Target Vessel Revascularization (TVR)(4 years)
- Number of Participants With Target Vessel Failure (TVF)(4 years)
- Number of Participants With Target Lesion Failure (TLF)(4 years)
- Number of Participants With Stent Thrombosis(4 years)
- Number of Participants With Occurrence of Stent Fracture at Target Lesion(4 years)