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NCT00228384 · ClinicalTrials.gov registry record · Phase 4
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
A Phase 4 study, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- Phase 4
- Development phase
- 148
- Enrollment target
NCT00228384: Completed Phase 4 study, sponsored by W.L.Gore & Associates.
NCT00228384 is a Phase 4 study that has completed, run by W.L.Gore & Associates. The registered enrollment target is 148 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00228384, a Phase 4 study, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 148 participants
- Enrollment target
Study Summary
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
Primary Outcome
Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end
Interventions
- DEVICE GORE VIABAHN Endoprosthesis
- DEVICE Bare Nitinol Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2005-09 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
What the finished NCT00228384 record still lists
NCT00228384 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which GORE VIABAHN Endoprosthesis is the first listed.
NCT00228384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00228384 about?
NCT00228384 is a clinical study titled "GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study". To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
What is the current status of trial NCT00228384?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 148 participants. The study started on 2005-09. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00228384?
The interventions under investigation include: GORE VIABAHN Endoprosthesis (DEVICE), Bare Nitinol Stent (DEVICE).
Who is sponsoring clinical trial NCT00228384?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00228384's enrollment target sits among peer trials
148 567th of 2000 higher than 1,431 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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