Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Medtronic Endovascular31 sites in 1 country419 target enrollmentApril 2004

ConditionsCarotid Artery Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Carotid Artery Disease
Sponsor: Medtronic Endovascular
Enrollment: 419
Locations: 31
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
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

October 2005

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Endovascular

Responsible Party

Sponsor

Eligibility Criteria

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)