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Carotid Revascularization With ev3 Arterial Technology Evolution (CREATE) Trial
NCT00619775 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00619775
The ClinicalTrials.gov registry entry for NCT00619775 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 419 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Endovascular, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00619775 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Indiana, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00619775?
This trial is sponsored by Medtronic Endovascular, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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