Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Phase 3

Completed

• Conditions: Carotid Artery Disease

• Registration Number: NCT00619775
• Lead Sponsor: Medtronic Endovascular

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 Description

Not available

Study Timeline

• Study Start: 2004-04
• Study Completion: 2005-10
• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-21
• Status Verified: 2008-12
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	30 days and one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (31)

Banner Baywood Heart Hospital; 🇺🇸 Mesa, Arizona, United States

Scripps Memorial Hospital; 🇺🇸 La Jolla, California, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Hoag Memorial Hospital; 🇺🇸 Newport Beach, California, United States

Salinas Valley Memorial Healthcare System; 🇺🇸 Salinas, California, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

St. Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

St. Vincent Hospital & Health Care Centers; 🇺🇸 Indianapolis, Indiana, United States

The Heart Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Kramer & Crouse Cardiology; 🇺🇸 Shawnee Mission, Kansas, United States

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