NCT02978456已完成不适用
Quantitative Coronary Angiography Versus Intravascular Ultrasound GUIDancE for Drug-Eluting Stent Implantation: GUIDE-DES Trial
CHEOL WHAN LEE, M.D., Ph.D6 个研究点 分布在 1 个国家目标入组 1,528 人开始时间: 2017年2月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,528
- 试验地点
- 6
- 主要终点
- Target lesion failure
研究概览
简要总结
The purpose of this study is to compare clinical outcomes between quantitative coronary angiography -guided and Intravascular ultrasound -guided strategy in patients with significant coronary artery disease undergoing sirolimus-eluting Orsiro/Orsiro mission stent implantation.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 19years of age
- •Typical chest pain or objective evidence of myocardial ischemia suitable for elective PCI
- •Significant coronary artery lesions suitable for sirolimus-eluting Orsiro/Orsiro mission stent implantation
- •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
- •Angiographic exclusion criteria: any of the followings 1)Bypass graft lesions 2)Impaired delivery of IVUS is expected:
- •Extreme angulation (≥90°) proximal to or within the target lesion.
- •Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- •Heavy calcification proximal to or within the target lesion.
- •Previous percutaneous coronary intervention within 6 months before the index procedure
- •Previous BVS (bioresorbable vascular scaffold) implantation
- •Left ventricular ejection fraction (LVEF) < 30%
- •Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- •Persistent thrombocytopenia (platelet count <100,000/µl)
- •Any history of hemorrhagic stroke or intracranial hemorrhage, Transient ischemic attack or ischemic stroke within the past 6 months
- •A known intolerance to antiplatelet agents (aspirin, clopidogrel, prasugrel or ticagrelor)
- •Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.
- •A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- •Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
- •Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal).
- •Life expectancy < 1 years for any non-cardiac or cardiac causes
- •Unwillingness or inability to comply with the procedures described in this protocol.
- •Patient's pregnant or breast-feeding or child-bearing potential.
研究组 & 干预措施
quantitative coronary angiography guided
Experimental
干预措施: quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent (Device)
Intravascular ultrasound guided
Active Comparator
干预措施: intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent (Device)
结局指标
主要结局
Target lesion failure
时间窗: 12 months
the cumulative incidence of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization at 12 months after the index procedure.
次要结局
- Death (cardiac, vascular, non-cardiovascular)(12 months)
- Target lesion revascularization(12 months)
- Myocardial infarction(12 months)
- Economic analysis(12 months)
- Procedural success(24 hours)
- Stent thrombosis (definite/probable)(12 months)
- Stroke(12 months)
- Any revascularization(12 months)
研究者
CHEOL WHAN LEE, M.D., Ph.D
professor, Division of Cardiology, Department of Internal Medicine
Asan Medical Center
研究点 (6)
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