Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
NCT00619775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419
Last updated 2021-05-14
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.
Conditions
- Carotid Artery Disease
Interventions
- DEVICE
-
PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Carotid artery stenting with distal embolic protection.
Sponsors & Collaborators
-
Medtronic Endovascular
lead INDUSTRY
Principal Investigators
-
Robert Safian, MD · William Beaumont Hospitals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-04-30
- Completion
- 2005-10-31
Countries
- United States
Study Locations
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