NCT01638507已完成不适用
Resolute Integrity US A Postapproval Study of the Medtronic Resolute™ Integrity 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 4.2 mm
Medtronic Vascular2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2012年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
研究概览
简要总结
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
详细描述
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
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
- •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
- •Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm
- •General and Angiographic
排除标准
- •highlights:
- •Within 7 days of index procedure platelet count <100,000 cells/mm³ or >700,000 cells/mm³; White Blood Cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
- •Acute MI within 72 hrs of the intended trial procedure (QWMI or any elevation of Creatine Kinase-MB (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 Transient Ischemic Attack (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
研究组 & 干预措施
Resolute Integrity
Other
Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity Stent)
干预措施: Resolute Integrity Stent (Device)
结局指标
主要结局
Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)
时间窗: 12 months
次要结局
- Clinical Endpoint: TLR(12 months)
- Clinical Endpoint: TVR(12 months)
- Clinical Endpoint: ST(12 months)
- Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI(12 months)
- Clinical Endpoint: Death(12 months)
- Dual Antiplatelet Therapy (DAPT) Compliance(12 months)
- Clinical Endpoint: Stroke(12 months)
- Clinical Endpoint: MI(12 months)
- Clinical Endpoint: Bleeding Complications in General(12 months)
研究者
研究点 (2)
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