NCT02831218终止不适用
Quantitative Coronary Angiography Versus Imaging GUIDancE for Bioresorbable Vascular Scaffold Implantation
Seung-Jung Park1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 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 compare clinical outcomes between QCA(quantitative coronary angiography)-guided and imaging-guided strategy in patients with native coronary artery disease undergoing Bioresorbable Vascular Scaffold implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Men or women at least 18 years of age
- •Typical chest pain or objective evidence of myocardial ischemia suitable for elective percutaneous coronary intervention
- •Native coronary artery lesions with lesion length ≤ 50mm and reference vessel diameter of 2.3 - 3.75mm by QCA(quantitative coronary angiography) assessment
- •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
- •Small vessel: mean reference size < 2.3 mm by QCA(quantitative coronary angiography)
- •True bifurcation lesion with a large side branch (reference vessel diameter > 2.3mm) requiring a complex two-stent approach
- •Left main lesions
- •Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending artery, or left circumflex artery
- •Impaired delivery of the Absorb BVS is expected:
- •Extreme angulation (≥90°) proximal to or within the target lesion.
- •Excessive tortuosity (≥two 45° angles) proximal to or within the target lesion.
- •Moderate or heavy calcification proximal to or within the target lesion.
- •In-stent restenotic lesions
- •ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
- •Prior percutaneous coronary intervention within the target vessel during the last 12 months.
- •Prior percutaneous coronary intervention within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
- •Left ventricular ejection fraction (LVEF) < 30%
- •Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) 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 (TIA) or ischemic stroke within the past 6 months
- •A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
- •Patients requiring long-term oral anticoagulants or cilostazol
- •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 < 5 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
QCA and Aspirin alone
Experimental
干预措施: QCA and Aspirin (Procedure)
QCA and Clopidogrel alone
Experimental
干预措施: QCA and Clopidogrel (Procedure)
Imaging guided and Aspirin alone
Active Comparator
干预措施: Imaging guided and Aspirin (Procedure)
Imaging guided and Clopidogrel alone
Active Comparator
干预措施: Imaging guided and Clopidogrel (Procedure)
结局指标
主要结局
Target lesion failure
时间窗: 1 year
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
- Procedural success(24 hours)
- Death(1 year and 5 years)
- Myocardial infarction(1 year and 5 years)
- Scaffold thrombosis(1 year and 5 years)
- Stroke(1 year and 5 years)
- Target lesion revascularization(1 year and 5 years)
- Any revascularization(1 year and 5 years)
- Target lesion failure(1 year and 5 years)
- event rate of net clinical events(5 years)
- Device success(1 day)
研究者
Seung-Jung Park
professor of medicine
Asan Medical Center
研究点 (1)
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