NCT03118531已完成不适用
Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.
Medtronic Vascular2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Late lumen loss, in stent
研究概览
简要总结
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
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
- •The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute Integrity 34/38 mm stent
- •The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent
排除标准
- •STEMI within 24 hours
- •Left main disease
- •Bifurcation disease
结局指标
主要结局
Late lumen loss, in stent
时间窗: 9 months (m)
Late lumen loss measured by quantitative coronary angiography (QCA)
次要结局
- Major Adverse Cardiac Events (MACE)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- Death(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- Target Lesion Failure (TLF)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- Myocardial infarction(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- Stent Thrombosis (ST)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- All revascularizations(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- Target Vessel Failure (TVF)(30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years)
- Device Success(At the end of index procedure, an expected average of 3 days)
- Lesion Success(At the end of index procedure, an expected average of 3 days)
- Procedure Success(Duration of hospital stay, an expected average of 5 days)
- In-stent and in-segment percent diameter stenosis (%DS)(9 months)
- In-stent and in-segment binary restenosis rate(9 months)
- In-stent and in-segment minimal luminal diameter (MLD)(9 months)
- In-segment late luminal loss(9 months)
研究者
研究点 (2)
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