Clinical Trial: SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
Brief Summary: 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).
Detailed Summary: Carotid Artery Stenting
Sponsor: Cordis Corporation
Current Primary Outcome: Any death, stroke or any MI [ Time Frame: up to 30-days post-procedure ]
Original Primary Outcome:
Current Secondary Outcome:
- 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 [ Time Frame: 30 days ]
- Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled [ Time Frame: Every follow-up where a PRO instrument QoL was assessed ]
- Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment [ Time Frame: 1 year ]
Original Secondary Outcome:
Information By: Cordis Corporation
Dates:
Date Received: November 20, 2006
Date Started: October 2006
Date Completion: November 2014
Last Updated: February 7, 2014
Last Verified: February 2014
