A Clinical Evaluation of the Medtronic Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Lesions in Native Coronary Arteries With a Reference Vessel Diameter of 2.25 mm to 4.2mm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,516
- 试验地点
- 2
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.
详细描述
The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •General and Angiographic Inclusion Criteria highlights:
- •Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
- •Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
- •Informed consent
- •Patient agrees to comply with specified follow-up evaluations at same investigational site
- •Single target lesion or two target lesions located in separate coronary arteries
- •De novo lesion(s) in native coronary artery(ies)
- •Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
- •Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)
- •General and Angiographic
排除标准
- •highlights:
- •Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; WBC count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
- •Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB > lab upper limit of normal)
- •Previous PCI of target vessel(s) within 9 months prior to the procedure
- •Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
- •History of stroke or TIA within prior 6 months
- •Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
- •Inability to comply with required trial antiplatelet regimen
- •Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
- •Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
- •Unprotected left main coronary artery disease
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 Months
Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
次要结局
- Major Adverse Cardiac Event (MACE)(12 months)
- Target Vessel Failure (TVF)(12 months)
- Death(12 months)
- Stent Thrombosis (ST)(12 months)
- Target Vessel MI(12 months)