NCT01681381Unknown不适用
A Prospective, Open Label, Randomized Study to Evaluate Safety And Effectiveness Of The Tivoli® Biodegradable Polymer Rapamycin-Eluting Stent and The FIREBIRD2® Rapamycin-Eluting Coronary CoCr Stent For Treatment Coronary Revascularization
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 2,790
- 试验地点
- 1
- 主要终点
- Ischemia-driven Target Lesion Failure (TLF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target lesion revascularization (TLR) at 12 months post-procedure.
研究概览
简要总结
This is a prospective, multi-center, open label, randomized study to evaluate the efficacy and safety of The TIVOLI Biodegradable polymer Rapamycin-Eluting Stent comparing with The FIREBIRD2™ Rapamycin-eluting Stent (DES) for Treatment Coronary Revascularization.
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
- •• The patient must be ≥18 of age;
- •Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia including chronic stable coronary artery disease, or acute coronary syndrome including non-ST-elevation and ST-elevation myocardial infarction;
- •Acceptable candidate for CABG;
- •The patient is willing to comply with specified follow-up evaluations;4.Patients who agree to accept the follow-up visits.
- •Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form.
- •Angiographic Inclusion criteria:
- •At least one lesion with a diameter stenosis >70% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;
- •Patients with multi-lesion or multi-vessel coronary disease, must have successful treatment (<30% diameter stenosis visual estimate) of the first treated lesion prior to treatment of other lesions at the same brand of stent. Staged (planned) procedures must be performed within 30 days of the index procedure.
排除标准
- •General Exclusion Criteria
- •Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure.
- •Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with dual antiplatelet therapy for at least 1 year;
- •Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- •Left ventricular function <40%;
- •Cardiogenic shock or hemodynamic compromise requiring pressors and/or inotropes or mechanical support;
- •Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, Rapamycinry , styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
- •Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
- •Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
- •Existing impairment in liver and kidney.
- •Extremely tortuous and/or calcification lesions.
- •Angiographic exclusion criteria:
- •Two or more chronic total occlusions in the proximal half of the epicardial coronary artery which cannot be recannalized.
结局指标
主要结局
Ischemia-driven Target Lesion Failure (TLF) which is a composite of cardiac death, myocardial infarction (Q and non-Q wave) and target lesion revascularization (TLR) at 12 months post-procedure.
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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