KCT0002921终止未知
HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging versus Quantative Coronary Angiography guidance
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
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
- •1Angiographic exclusion criteria: any of the followings
- •1)Small vessel: mean reference size < 2.5 mm by quantitative coronary angiography
- •2)True bifurcation lesion with a large side branch (reference vessel diameter > 2.5mm) requiring a complex two-stent approach
- •3)Left main lesions
- •4)Ostial lesions within 3mm of the origin: right coronary artery, left anterior descending, or left circumflex artery
- •5)Impaired delivery of the Absorb bio- resorbable vascular scaffold is expected:
- •a.Extreme angulation (=90°) proximal to or within the target lesion.
- •b.Excessive tortuosity (=two 45° angles) proximal to or within the target lesion.
- •2ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (with 12- 24 hour after symptoms onset)
- •3Prior 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.
- •4Left ventricular ejection fraction (LVEF) < 30%
- •5Hypersensitivity 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.
- •6Persistent thrombocytopenia (platelet count <100,000/µl)
- •7Any history of hemorrhagic stroke or intracranial hemorrhage, transient ischemic attack or ischemic stroke within the past 6 months
- •8A known intolerance to a study drug (aspirin, clopidogrel or ticagrelor)
- •9Patients requiring long-term oral anticoagulants or cilostazol
- •10Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate(ADP) antagonist is planned within 12 months after the procedure.
- •11A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
- •12Any 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.
- •13Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alanine transaminase (ALT) or aspartate transaminase (AST) > 3 times upper limit of normal).
- •14Life expectancy < 5 years for any non-cardiac or cardiac causes
- •15Unwillingness or inability to comply with the procedures described in this protocol.
- •16pregnant or breast-feeding or child-bearing potential.
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