Clinical Trial: Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Brief Summary: Evaluate the safety and efficacy of the Protege Stent and Spider Device in the treatment of common and/or internal carotid artery stenoses for subjects that are high risk for carotid endarterectomy.
Detailed Summary:
Sponsor: ev3
Current Primary Outcome: Myocardial infarction, ipsilateral cerebrovascular accident, procedure-related contralateral CVA or death within 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation [ Time Frame: 30 days and one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation [ Time Frame: 30 days and one year ]
- Target lesion revascularization [ Time Frame: one year ]
- Target vessel revascularization [ Time Frame: one year ]
- Primary patency at one year (<70% stenosis as measured by duplex scan) [ Time Frame: one year ]
- Technical success (defined as the ability to deploy the filter, place the stent over the filter wire, and recapture the filter with the resulting residual stenosis <50%) [ Time Frame: at implant ]
Original Secondary Outcome: Same as current
Information By: ev3
Dates:
Date Received: February 7, 2008
Date Started: April 2004
Date Completion:
Last Updated: December 5, 2008
Last Verified: December 2008
