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Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

NCT00120406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2014-08-11

Study results available
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Summary

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).

Conditions

  • Peripheral Vascular Diseases

Interventions

DEVICE

Zilver® PTX™ Drug Eluting Vascular Stent

Stenting of the Superfemoropopliteal Artery

PROCEDURE

Angioplasty

Angioplasty of the Superfemoropopliteal Artery

Sponsors & Collaborators

  • William Cook Europe

    collaborator INDUSTRY

  • MED Institute, Incorporated

    collaborator INDUSTRY

  • Cook Japan Incorporated

    collaborator INDUSTRY

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Michael Dake, M.D. · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2009-10-31
Completion
2014-02-28

Countries

  • United States
  • Germany
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120406 on ClinicalTrials.gov