NCT03175523终止不适用
HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance
Seung-Jung Park1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年9月29日最近更新:
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
- 84
- 试验地点
- 1
- 主要终点
- Target lesion failure
研究概览
简要总结
The objective of this trial is to compare clinical outcomes between imaging-guided and QCA-guided strategy in patients with native coronary artery disease undergoing BRS implantation.
详细描述
The investigators hypothesized that intravascular imaging-guided BRS implantation is superior to QCA-guided BRS implantation with respect to target lesion failure in patients with native coronary artery disease.
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 19 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 less and reference vessel diameter of 2.5 ~ 3.75mm by 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 < 2.5 mm by 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, or left circumflex artery
- •Impaired delivery of the Absorb bio- resorbable vascular scaffold 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 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 Adenosine diphosphate(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 (alanine transaminase (ALT) or aspartate transaminase (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-guided Bioresorbable scaffold
Experimental
quantitative coronary angiography guided Bioresorbable scaffold
干预措施: quantitative coronary angiography guided Bioresorbable scaffold implantation (Device)
Imaging guided Bioresorbable scaffold
Active Comparator
干预措施: imaging guided Bioresorbable scaffold implantation (Device)
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
- Stroke(1 year, and 5 years)
- Device success(1 hour after an index procedure)
- Procedural success(24 hours after an index procedure)
- Myocardial infarction(1 year, and 5 years)
- Target lesion revascularization(1 year, and 5 years)
- In-scaffold restenosis on coronary CT angiography(1 year, and 5 years)
- Target lesion failure (TLR)(1 year, and 5 years)
- A composite event(1 year, and 5 years)
- Any revascularization(1 year, and 5 years)
- Death(1 year, and 5 years)
- Scaffold thrombosis(1 year, and 5 years)
研究者
Seung-Jung Park
Professor
Asan Medical Center
研究点 (1)
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