Status:
COMPLETED
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
Lead Sponsor:
Medtronic Endovascular
Conditions:
Carotid Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
419 Patients enrolled
Trial Details
Trial ID
NCT00619775
Start Date
April 1 2004
End Date
October 1 2005
Last Update
May 14 2021
Active Locations (31)
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1
Banner Baywood Heart Hospital
Mesa, Arizona, United States, 85205
2
Scripps Memorial Hospital
La Jolla, California, United States, 92037
3
El Camino Hospital
Mountain View, California, United States, 94040
4
Hoag Memorial Hospital
Newport Beach, California, United States, 92663