Clinical Trial: Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)
Brief Summary: The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.
Detailed Summary:
Sponsor: Abbott Vascular
Current Primary Outcome: Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years. [ Time Frame: 3 years ]
Original Primary Outcome: Composite of any stroke, myocardial infarction and death during the 30-day post procedural period and ipsilateral strokes between 31 and 365 days
Current Secondary Outcome:
- Acute Device Success [ Time Frame: Post-procedure ]Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.
- Procedural Success [ Time Frame: 30 Days ]Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.
- Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax [ Time Frame: ≤30 days ]Includes only each subject's first occurrence of each event.
- Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years. [ Time Frame: 3 years ]
Original Secondary Outcome:
- 0-30 days Post-procedure:
- Acute Device Success
- Procedural success12 months
- Post-procedure:
- Freedom from clinically driven target lesion revascularization at 12 months
Information By: Abbott Vascular
Dates:
Date Received: November 20, 2006
Date Started: November 2006
Date Completion:
Last Updated: May 17, 2012
Last Verified: May 2012