NCT02831205终止4 期
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
Duk-Woo Park, MD1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2016年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Target lesion failure
研究概览
简要总结
The purpose of this study is to determine whether ABSORB bioresorbable vascular scaffold is non-inferior to XIENCE everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (TLF) at 1 year.
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
- •Age 18 and more
- •Diffuse long native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment
- •Patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including NSTEMI or STEMI
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site
排除标准
- •Subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated
- •Subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication
- •An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure
- •STEMI requiring primary percutaneous coronary intervention
- •Cardiogenic shock
- •Restenotic lesions
- •Left main
- •Extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion
- •Heavy calcification proximal to or within the target lesion
- •Compromised left ventricular dysfunction (LVEF <30%)
- •At the time of screening, the subject has a malignancy that is not in remission
- •Terminal illness with life expectancy <1 year
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
- •Patient's pregnant or breast-feeding or child-bearing potential
研究组 & 干预措施
ABSORB BVS
Experimental
干预措施: everolimus-eluting bioresorbable vascular (Absorb) scaffold (Device)
XIENCE EES
Active Comparator
干预措施: everolimus-eluting cobalt-chromium (Xience) stent (Device)
结局指标
主要结局
Target lesion failure
时间窗: 1 year
event rate for composite of cardiac death, target-vessel myocardial infarction \[MI\], or ischemia-driven target-lesion revascularization
次要结局
- Cardiac death(5 years)
- Target-vessel myocardial infarction(5 years)
- Ischemia-driven target-lesion revascularization(5 years)
- All-cause mortality(5 years)
- event rate of any myocardial infarction; Q-wave vs Non-Q wave, periprocedural myocardial infarction vs follow-up myocardial infarction(5 years)
- Any revascularization(5 years)
- Target-vessel failure(5 years)
- Stent thrombosis(5 years)
- event rate of device success or procedural success(5 years)
- Patient-reported angina status measured by Seattle angina questionnaire(5 years)
研究者
Duk-Woo Park, MD
professor of medicine
Asan Medical Center
研究点 (1)
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