NCT00619775CompletedPhase 3
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Medtronic Endovascular62 sites in 1 country419 target enrollmentStarted: April 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 419
- Locations
- 62
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years and above
- •informed consent
- •for female subjects, not pregnant or planning on becoming pregnant
- •meet protocol defined anatomical or clinical high risk criteria
Exclusion Criteria
- •participation in another clincial study which may affect either the pre-procedure or follow-up results
- •prior stenting of the ipsilateral carotid artery
- •life expectancy less than twelve months
- •known allergy or intolerance of study medications or device materials
- •must not meet general or angiographic exclusion criteria as defined in the protocol
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation(30 days and one year)
- Target vessel revascularization(one year)
- Target lesion revascularization(one year)
- Primary patency at one year (<70% stenosis as measured by duplex scan)(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%)(at implant)
Investigators
Study Sites (62)
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