Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial

Completed · Phase 3

Conditions studied: Carotid Artery Disease

In brief

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.

Key facts

Study ID

NCT00619775

Run by

Medtronic Endovascular

People needed

419

Starts

2004-04-01

Expected to finish

2005-10-01

Last updated by the study team

2021-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 D.C., 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
• Terrebonne General Hospital — Houma, Louisiana, United States
• Southwest Medical Center — Lafayette, Louisiana, United States
• Union Memorial Hospital — Baltimore, Maryland, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Oakwood Hospital — Dearborn, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• St. Louis University Medical Center — St Louis, Missouri, United States
• University of Buffalo Millard Fillmore Hospital — Buffalo, New York, United States
• Duke University Medical Center — Raleigh, North Carolina, United States
• Wake Heart Associates — Raleigh, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Riverside Methodist — Columbus, Ohio, United States
• Holy Spirit Hospital — Harrisburg, Pennsylvania, United States
• Hahnemann University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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