NCT02681341已完成不适用
Vascular Post Market Review
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 6 Month Duplex US Report to Measure Material Quality
研究概览
简要总结
The primary objective of this study is to confirm that properties of CardioCel provide operative benefit to surgeons when compared to Dacron, CorMatrix, and all other bovine pericardium not treated with proprietary ADAPT engineering.
详细描述
ENDPOINTS
- OR experience: suturability, handling, hemostasis, compliance to recipient vessel, blood loss, OR time.
- In-hospital survival
- MAE (Stroke, MI, death)
- 1 Month duplex US scan
- 6 month duplex US scan
Secondary Efficacy Endpoints
- Less than 50% stenosis at 6 months (PSV <150 cm/s)
Safety Endpoint
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Scheduled for carotid endarterectomy (CEA) with patch arterioplasty
- •Expected lifespan of over 24 months
- •Age over 18 years
排除标准
- •Revision of previous CEA arterioplasty
- •Active infection
- •Cerebral ischemic event (completed stroke) within 30 days of planned surgery
- •Pregnant or breastfeeding
- •Concomitant surgical or endovascular procedure being performed
结局指标
主要结局
6 Month Duplex US Report to Measure Material Quality
时间窗: Up to 6 months post CEA
The 6 month duplex US report will measure peak velocity and flow through the repaired carotid artery, caliber, and occlusion/lesion status as per normal parameters used in post-CEA scans.
次要结局
- OR Data and Surgeon Feedback During the Procedure(procedure)
研究者
研究点 (1)
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