NCT00403078已完成不适用
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21,008
- 试验地点
- 5
- 主要终点
- Any death, stroke or any MI
研究概览
简要总结
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
详细描述
Carotid Artery Stenting
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •High-surgical risk patients to be treated consistent with IFU labeling
- •The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee.
排除标准
- •Patients not treated per the IFU
- •Patients who are contraindicated per the IFU
- •Patients previously enrolled in the study
- •Patients requiring stenting of in-stent restenosis after CAS
- •Inability or refusal to provide informed consent.
结局指标
主要结局
Any death, stroke or any MI
时间窗: up to 30-days post-procedure
次要结局
- Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled(Every follow-up where a PRO instrument QoL was assessed)
- Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3(30 days)
- Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment(1 year)
研究者
研究点 (5)
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