Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Carotid Artery Disease Clinical Trial

— CREATE  

Official title:

Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619775
• Other study ID #: P-1007
• Status: Completed
• Phase: Phase 3
• Start date: April 2004
• Est. completion date: October 2005

Study information

• Verified date: December 2008
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

Device:
• PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Carotid artery stenting with distal embolic protection.

Locations

Country	Name	City	State
United States	Union Memorial Hospital	Baltimore	Maryland
United States	University of Buffalo Millard Fillmore Hospital	Buffalo	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Riverside Methodist	Columbus	Ohio
United States	Oakwood Hospital	Dearborn	Michigan
United States	Greenville Hospital System	Greenville	South Carolina
United States	Holy Spirit Hospital	Harrisburg	Pennsylvania
United States	Terrebonne General Hospital	Houma	Louisiana
United States	St. Vincent Hospital & Health Care Centers	Indianapolis	Indiana
United States	The Heart Center of Indiana	Indianapolis	Indiana
United States	Baptist Heart Institute	Knoxville	Tennessee
United States	Scripps Memorial Hospital	La Jolla	California
United States	Southwest Medical Center	Lafayette	Louisiana
United States	Banner Baywood Heart Hospital	Mesa	Arizona
United States	El Camino Hospital	Mountain View	California
United States	Hoag Memorial Hospital	Newport Beach	California
United States	St. Francis Medical Center	Peoria	Illinois
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Duke University Medical Center	Raleigh	North Carolina
United States	Wake Heart Associates	Raleigh	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St. Louis University Medical Center	Saint Louis	Missouri
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	Swedish Medical Center	Seattle	Washington
United States	Kramer & Crouse Cardiology	Shawnee Mission	Kansas
United States	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Washington Hospital Center	Washington	District of Columbia
United States	Pinnacle Health at Harrisburg Hospital	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

Country where clinical trial is conducted

United States, 

References & Publications (2)

Safian RD, Bacharach JM, Ansel GM, Criado FJ. Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid revascularization with ev3 arterial technology evolution (CREATE) feasibility trial. Catheter Ca — View Citation

Safian RD, Bresnahan JF, Jaff MR, Foster M, Bacharach JM, Maini B, Turco M, Myla S, Eles G, Ansel GM; CREATE Pivotal Trial Investigators. Protected carotid stenting in high-risk patients with severe carotid artery stenosis. J Am Coll Cardiol. 2006 Jun 20; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Target lesion revascularization		one year
Secondary	Target vessel revascularization		one year
Secondary	Primary patency at one year (<70% stenosis as measured by duplex scan)		one year
Secondary	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