NCT00914979终止3 期
AngioSculpt Scoring Balloon Catheter For Bifurcation Coronary Lesions (ABC Study) Prospective, Multi-center, Non-randomized, Single-arm Registry
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE
研究概览
简要总结
Assess the impact of lesion preparation using the AngioSculpt balloon in the treatment of bifurcation lesions in native coronary arteries.
详细描述
The purpose of the AngioSculpt® Scoring Balloon Catheter For Bifurcation Coronary lesions (ABC registry) is to demonstrate the acute procedural success, device performance and long term outcome associated with use of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) for lesion preparation in the treatment of bifurcation lesions in native coronary arteries
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with significant (≥ 50% diameter stenosis) native coronary artery disease involving a bifurcation (Medina class (x,x,1)).
排除标准
- •Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
- •Additional planned coronary interventions for a non-target lesion within 30 days of the study procedure.
结局指标
主要结局
Procedural success ≤ 50% diameter stenosis of the main and the side branch at the conclusion of the procedure in the absence of in-hospital MACE
时间窗: 9 Months
次要结局
- Rate of side branch stenting(9 Months)
- Angiographic dissection rate and grade(9 months)
- MACE rate at 30 days post-procedure(9 months)
- Cumulative stent thrombosis and TLR rates at 9 months(9 months)
研究者
研究点 (5)
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