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NCT00619775 · ClinicalTrials.gov registry record · Phase 3
Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
A Phase 3 study of Carotid Artery Disease, sponsored by Medtronic Endovascular.
- Completed
- Registry status
- Phase 3
- Development phase
- 419
- Enrollment target
- 20
- Study locations
NCT00619775: Completed Phase 3 study of Carotid Artery Disease, sponsored by Medtronic Endovascular.
NCT00619775 is a Phase 3 study of Carotid Artery Disease that has completed, run by Medtronic Endovascular. The registered enrollment target is 419 participants, below the 13,649-participant average among 5 other Carotid Artery Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619775, a Phase 3 study of Carotid Artery Disease, has completed, sponsored by Medtronic Endovascular.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 419 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DEVICE PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device
Study Locations (20)
California
- Scripps Memorial Hospital - La Jolla
- El Camino Hospital - Mountain View
- Hoag Memorial Hospital - Newport Beach
- Salinas Valley Memorial Healthcare System - Salinas
Indiana
- St. Vincent Hospital & Health Care Centers - Indianapolis
- The Heart Center of Indiana - Indianapolis
Louisiana
- Terrebonne General Hospital - Houma
- Southwest Medical Center - Lafayette
Maryland
- Union Memorial Hospital - Baltimore
- Washington Adventist Hospital - Takoma Park
Michigan
- Oakwood Hospital - Dearborn
- William Beaumont Hospital - Royal Oak
North Carolina
- Duke University Medical Center - Raleigh
- Wake Heart Associates - Raleigh
Arizona
- Banner Baywood Heart Hospital - Mesa
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
What the finished NCT00619775 record still lists
NCT00619775 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, below the 13,649-participant average among 5 other Carotid Artery Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Carotid Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device is the first listed.
NCT00619775 names 20 study sites across 12 states, led by California, Indiana, Louisiana.
Frequently Asked Questions
What is clinical trial NCT00619775 about?
NCT00619775 is a clinical study titled "Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial". 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.
What is the current status of trial NCT00619775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 419 participants. The study started on 2004-04. Estimated completion is 2005-10.
What conditions does trial NCT00619775 study?
This clinical trial studies the following conditions: Carotid Artery Disease.
What interventions are being tested in trial NCT00619775?
The interventions under investigation include: PROTÉGÉ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and Spider Embolic Protection Device (DEVICE).
Who is sponsoring clinical trial NCT00619775?
This trial is sponsored by Medtronic Endovascular, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00619775 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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