NCT00264043已完成2 期
Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
研究概览
简要总结
The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.
详细描述
This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.
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
- •Unstable angina pectoris (Braunwald classification B & C, I-II-III, native vessels)
- •or lesion located in the SVG;
- •Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft;
- •The vessel diameter to place the AngioGuard™ device in must be > 3 and < 5.5 mm (6.5 when the 7mm AngioGuard™ is available);
- •Target lesion stenosis is >50% and <100% (TIMI 1).
排除标准
- •A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- •More than one coronary artery is 100% occluded;
- •Patient has unprotected left main coronary disease with > 50% stenosis;
- •Patient has an ostial target lesion;
- •Significant (>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff;
- •Ejection fraction <30%;
- •Totally occluded vessel (TIMI 0 Level).
结局指标
主要结局
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
时间窗: 1 month
次要结局
- successful placement and retrieval without embolic occlusions of vessels distal to the position of the device(post-procedure)
- overall survival rates(1 month and 6 months)
- device evaluation(post-procedure)
研究者
研究点 (2)
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