NCT01569594已完成不适用
CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 6
- 主要终点
- Carotid Procedure and Device Related Adverse Events to Determine Device Performance
研究概览
简要总结
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
详细描述
The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be undergoing carotid endarterectomy with patch angioplasty closure.
- •Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use.
- •The subject must possess the ability to provide written Informed Consent.
- •The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol.
排除标准
- •Subjects with a known sensitivity to porcine material.
结局指标
主要结局
Carotid Procedure and Device Related Adverse Events to Determine Device Performance
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (6)
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