A Prospective, Single-arm, Multicenter 2-phase Feasibility Study to Assess the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System (TAXUS Petal)for the Treatment of de Novo Atherosclerotic Bifurcation Lesions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an investigational device with an indication of improving coronary artery luminal diameter while maintaining side branch access in subjects with symptomatic ischemic disease due to discrete atherosclerotic bifurcation lesions
详细描述
To assess the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System (TAXUS® Petal™) for the treatment of de novo atherosclerotic bifurcation lesions (by visual estimate):
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Phase 1:
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Main branch: 3.0 to 3.5 mm RVD and lesion length ≤20 mm
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Side branch: 2.5 to 3.5 mm RVD and lesion length ≤14 mm
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Phase 2:
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Main branch: 3.0 to 3.5 mm RVD and lesion length ≤28 mm
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Side branch: 2.25 to 3.5 mm RVD and lesion length ≤14 mm
Bifurcation main branch (MB) lesion length will be measured from the proximal shoulder of the most proximal lesion to the distal shoulder of the most distal lesion. Bifurcation side branch (SB) lesion length will be measured from the proximal shoulder of the side branch (if the ostium is disease-free) or the side branch ostium (if the disease continues into the main branch) to the distal side branch shoulder of the most distal lesion. At follow-up, the entire stented region will be used to determine MLD and %DS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite safety endpoint at 30 days post-procedure: • All-cause mortality • Documented myocardial infarction • TVR
时间窗: 30 days
次要结局
- Device Success Technical Success Clinical Procedural Success Device malfunctions Ease-of-Use parameters Clinical endpoints Main branch and side branch angiographic endpoints Main branch and side branch IVUS endpoints(Index procedure, 30 days, 6 months and 1 - 5 years)