NCT01205776已完成不适用
Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,905
- 试验地点
- 2
- 主要终点
- Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
研究概览
简要总结
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •* Inclusion criteria for RCT:
- •Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or
- •ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present:
- •Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or
- •IVUS minimum lumen area (MLA) <= 6.0mm2, and/or
- •Fractional Flow Reserve (FFR) <=0.80
- •Left Main Equivalent Disease
- •Clinical and anatomic eligibility for both PCI and CABG
- •Silent ischemia, stable angina, unstable angina or recent MI
- •Ability to sign informed consent and comply with all study procedures including follow-up for at least three years
排除标准
- •* Clinical exclusion criteria:
- •Prior PCI of the left main trunk at any time prior to randomization
- •Prior PCI of any other coronary artery lesions within one year prior to randomization
- •Prior CABG at any time prior to randomization
- •Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
- •CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated
- •Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
- •Subjects requiring or who may require additional surgery within one year
- •The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
- •The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
- •Pregnancy or intention to become pregnant
- •Non cardiac co-morbidities with life expectancy less than 3 years
- •Other investigational drug or device studies that have not reached their primary endpoint
- •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 permanently 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:
- •Left main diameter stenosis <50%
- •SYNTAX score ≥33
- •Left main reference vessel diameter <2.25 mm or >4.25 mm
- •The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
- •The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
结局指标
主要结局
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
时间窗: 5 years
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. 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. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
次要结局
- Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)(In-hospital (≤ 7 days of index-procedure))
- Number of Participants With Protocol Defined MI(0 to 5 years)
- Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)(0 to 5 years)
- Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable(Very late (>1 year))
- Number of Participants With Requirement for Blood Product Transfusion(5 years)
- Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke(0 to 5 years)
- Number of Participants With Disability Following Stroke Event(90 days ± 2 weeks)
- Number of Participants With Ischemia Driven Revascularizations(0 to 5 years)
- Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable(Late (>30 days - 1 year))
- Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)(0 to 5 years)
- Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)(0 to 5 years)
- Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)(In-hospital (≤ 7 days of index-procedure))
- Number of Participants With Graft Stenosis or Occlusion(0 to 5 years)
- Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia(0 to 5 years)
- Percentage of Participants With Major Adverse Events (MAE)(In-hospital)
- Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding(5 years)
- Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion(In-hospital (≤ 7 days of post index procedure))
- Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding(5 years)
- Number of Participants With Major Adverse Events (MAE)(30 days)
- Number of Participants With Complete Revascularization (Residual = 0)(At Baseline)
- Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion(5 years)
研究者
研究点 (2)
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