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COMPLETED NA

Evaluation of the GORE TIGRIS Vascular Stent

NCT01576055 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 267 participants
Start Date 2012-04
Est. Completion 2017-08
Phase NA

Sponsor

W.L.Gore & Associates

117 total trials

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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. It is categorized as NA, 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 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 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 Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions — of which TIGRIS Vascular Stent 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: NCT01576055 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Illinois, Florida, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01576055?

The interventions under investigation include: TIGRIS Vascular Stent (DEVICE), BARD LifeStent (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01576055?

This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial