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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 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
Prospective, multi-center, non-randomized, single-arm, open-label study 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 (RVD) of 2.25 mm to 4.2 mm in patients who receive extended length stents (34 mm or 38 mm) referred to as the Extended Length Study.
详细描述
The purpose of this postapproval study is to conduct a prospective, multi-center evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available 34 mm and 38 mm Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
Descriptive statistics and 95% confidence intervals will be calculated for clinically relevant variables as described in a separate statistical analysis plan.
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) ≤ 35 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 Myocardial Infarction (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
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
The combined clinical outcome of (all cause) mortality, MI or any revascularization
次要结局
- Composite Endpoint: Cardiac Death and Target Vessel MI(30 days, 6 months, 12 months)
- Clinical Endpoint: Target Lesion Revascularization (TLR)(30 days, 6 months, 12 months)
- Clinical Endpoint: Stroke(30 days, 6 months, 12 months)
- Clinical Endpoint: Bleeding Complications in General(30 days, 6 months, 12 months)
- Composite Endpoint: Target Lesion Failure (TLF)(30 days, 6 months, 12 months)
- Composite Endpoint: Target Vessel Failure (TVF),(30 days, 6 months, 12 months)
- Clinical Endpoint: Myocardial Infarction (MI)(30 days, 6 months, 12 months)
- Composite Endpoint: Target Vessel MI(30 days, 6 months, 12 months)
- Clinical Endpoint: Death(30 days, 6 months, 12 months)
- Dual Antiplatelet Therapy (DAPT) Compliance(30 days, 6 months, 12 months)
- Composite Endpoint: Major Adverse Cardiac Events (MACE)(30 days, 6 months, 12 months)
- Clinical Endpoint: Target Vessel Revascularization (TVR)(30 days, 6 months, 12 months)
- Clinical Endpoint: Stent Thrombosis(Early Thrombosis (<=30 days), Late Thrombosis (31-360 days))