Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial - Full Text View

Sponsored by:	ev3 Endovascular, Inc.
Information provided by:	ev3 Endovascular, Inc.
ClinicalTrials.gov Identifier:	NCT00619775

Purpose

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.

Condition	Intervention	Phase
Carotid Artery Disease	Device: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Resource links provided by NLM:

MedlinePlus related topics: Carotid Artery Disease

U.S. FDA Resources

Further study details as provided by ev3 Endovascular, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Target lesion revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
Target vessel revascularization [ Time Frame: one year ] [ Designated as safety issue: No ]
Primary patency at one year (<70% stenosis as measured by duplex scan) [ Time Frame: one year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	419
Study Start Date:	April 2004
Study Completion Date:	October 2005

Intervention Details:

Carotid artery stenting with distal embolic protection.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619775

Show 31 Study Locations

Sponsors and Collaborators

ev3 Endovascular, Inc.

Investigators

Principal Investigator:

Robert Safian, MD

William Beaumont Hospitals

More Information

Publications:

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;47(12):2384-9.

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 Cardiovasc Interv. 2004 Sep;63(1):1-6.

Responsible Party:	William Beaumont Hospital ( Robert Safian, MD )
Study ID Numbers:	P-1007
Study First Received:	February 7, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00619775 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ev3 Endovascular, Inc.:

Carotid Artery Disease
Embolic Protection

Study placed in the following topic categories:

Embolism
Vascular Diseases
Central Nervous System Diseases

Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Diseases

Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on September 11, 2009