Clinical trial NCT00619775: Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Official title: Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Artery Disease
Keywords: Carotid Artery Disease
Embolic Protection
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 30 days and one year
Secondary outcomes:
measure: Ipsilateral CVA, procedure-related contralateral CVA or death with 30 days of implantation; and ipsilateral CVA from 31 days to 1 year post-implantation
timeFrame: 30 days and one year
measure: Target lesion revascularization
timeFrame: one year
measure: Target vessel revascularization
timeFrame: one year
measure: Primary patency at one year (<70% stenosis as measured by duplex scan)
timeFrame: one year
measure: 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%)
timeFrame: at implant
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Baywood Heart Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Peoria
country: United States
facility: St. Francis Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital & Health Care Centers
state: Indiana
city: Indianapolis
country: United States
facility: The Heart Center of Indiana
state: Indiana
city: Shawnee Mission
country: United States
facility: Kramer & Crouse Cardiology
state: Kansas
city: Houma
country: United States
facility: Terrebonne General Hospital
state: Louisiana
city: Lafayette
country: United States
facility: Southwest Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo Millard Fillmore Hospital
state: New York
city: Raleigh
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Heart Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist
state: Ohio
city: Harrisburg
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of South Dakota
state: South Dakota
city: Knoxville
country: United States
facility: Baptist Heart Institute
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: William Beaumont Hospitals
name: Robert Safian, MD
role: PRINCIPAL_INVESTIGATOR
References:
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;47(12):2384-9. doi: 10.1016/j.jacc.2005.12.076.
citation: 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. doi: 10.1002/ccd.20155.