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NCT01576055 · ClinicalTrials.gov registry record · NA
Evaluation of the GORE TIGRIS Vascular Stent
A NA study of Peripheral Arterial Disease, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- NA
- Development phase
- 267
- Enrollment target
- 20
- Study locations
NCT01576055 is a NA study of Peripheral Arterial Disease that has completed, run by W.L.Gore & Associates. The registered enrollment target is 267 participants, below the 4,203-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT01576055, a NA study of Peripheral Arterial Disease, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 267 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).
Conditions Studied
Interventions
- DEVICE TIGRIS Vascular Stent
- DEVICE BARD LifeStent
Study Locations (20)
Illinois
- Northwestern University - Chicago
- Alexian Brothers Specialty Group - Elk Grove Village
- Heart Care Research Foundation - Mokena
- Advocate Christ Medical Center - Oak Lawn
- HeartCare MidWest - Peoria - Peoria
Florida
- First Coast Cardiovascular Institute, P.A - Jacksonville
- MediQuest Research at Munroe Regional - Ocala
- Orlando Regional Healthcare System - Orlando
- Coastal Vascular & Interventional - Pensacola
California
- North County Radiology - Oceanside
- UC Davis Vascular Center - Sacramento
- Kaiser Permanente San Francisco - San Francisco
Georgia
- Vascular Surgical Associates, PC - Austell
- Medical Center of Central Georgia - Macon
Alabama
- Cardiology Associates of Mobile - Mobile
Arkansas
- Arkansas Heart - Little Rock
Connecticut
- Yale University School of Medicine - New Haven
Hawaii
- Kaiser Permanente - Honolulu - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2012-04 |
| Est. Completion | 2017-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01576055
The ClinicalTrials.gov registry entry for NCT01576055 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,203-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (94% 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 Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which TIGRIS Vascular Stent is the first listed.
NCT01576055 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Illinois, Florida, California.
Frequently Asked Questions
What is clinical trial NCT01576055 about?
NCT01576055 is a clinical study titled "Evaluation of the GORE TIGRIS Vascular Stent". The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomat...
What is the current status of trial NCT01576055?
This trial is currently completed. It is a NA study. The enrollment target is 267 participants. The study started on 2012-04. Estimated completion is 2017-08.
What conditions does trial NCT01576055 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT01576055?
The interventions under investigation include: TIGRIS Vascular Stent (DEVICE), BARD LifeStent (DEVICE).
Who is sponsoring clinical trial NCT01576055?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01576055 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. 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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