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NCT00594100 · ClinicalTrials.gov registry record · Phase 3
GORE Embolic Protection With Reverse Flow
A Phase 3 study of Carotid Artery Stenosis, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
- 2
- Study locations
NCT00594100 is a Phase 3 study of Carotid Artery Stenosis that has completed, run by W.L.Gore & Associates. The registered enrollment target is 245 participants, below the 285-participant average among 4 other Carotid Artery Stenosis trials with a reported enrollment target (14% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00594100, a Phase 3 study of Carotid Artery Stenosis, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
- 2
- Study locations
Study Summary
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
Conditions Studied
Interventions
- DEVICE GORE Flow Reversal System (GFRS)
Study Locations (2)
New York
- Millard Fillmore Gates/Univ. of Buffalo - Buffalo
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00594100
The ClinicalTrials.gov registry entry for NCT00594100 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 4 other Carotid Artery Stenosis trials with a reported enrollment target (14% lower). The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Carotid Artery Stenosis appearing as the primary indexed condition, and to 1 intervention - of which GORE Flow Reversal System (GFRS) is the first listed.
NCT00594100 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT00594100 about?
NCT00594100 is a clinical study titled "GORE Embolic Protection With Reverse Flow". To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
What is the current status of trial NCT00594100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2006-07. Estimated completion is 2008-09.
What conditions does trial NCT00594100 study?
This clinical trial studies the following conditions: Carotid Artery Stenosis.
What interventions are being tested in trial NCT00594100?
The interventions under investigation include: GORE Flow Reversal System (GFRS) (DEVICE).
Who is sponsoring clinical trial NCT00594100?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00594100 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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