Clinical Trial: Carotid With Bivalirudin Angioplasty
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Carotid With Bivalirudin Angioplasty
Brief Summary: Single center randomized clinical trial, to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive carotid artery disease in low and high risk patient cohorts.
Detailed Summary:
Sponsor: Medstar Health Research Institute
Current Primary Outcome: To evaluate clinical success (<50% residual stenosis at all treatment sites without death, myocardial infarction, stroke or major bleed) [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To assess for complications including death, myocardial infarction, major or minor stroke, major or minor bleeding, and vascular complications. [ Time Frame: In hospital and 30 days ]
- To assess stent patency , and occurence of death or recurrent neurological events [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Medstar Health Research Institute
Dates:
Date Received: December 18, 2008
Date Started: August 2003
Date Completion:
Last Updated: October 31, 2013
Last Verified: October 2013
