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

July 21, 2014 updated by: Cook Group Incorporated
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 above-the-knee femoropopliteal artery is defined as the superficial femoral artery (SFA) and the region of the popliteal artery above the plane of the femoral epicondyles. 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 FDA.

This study will include 480 patients who will receive the Zilver PTX stent or Percutaneous transluminal angioplasty (PTA) at up to 100 investigational sites. Clinical data will be captured on paper and electronic case report forms. Analyses will include evaluation of the composite event-free survival rate and the patency rate at 6- and 12-month follow-up. Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6. Patency will be assessed by duplex ultrasound in all patients. Patients may be randomized to one or more of the following sub-studies: IVUS and angiography at 6 months (stent patients only), angiography at 12 months, pharmacokinetic substudy (Zilver PTX patients only), or ultrasound (PTA patients only). The trial also includes provisions for patients experiencing PTA failure. These patients may be randomized to receive a Zilver PTX stent or a bare Zilver stent.

Study Type

Interventional

Enrollment (Actual)

474

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany, 79189
        • Herz-Zentrum
      • Leipzig, Germany, 04177
        • Gemeinschaftspraxis
      • Leipzig, Germany, 04289
        • Heart Center Leipzig, Angiology
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg
  • Japan
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Nara-city, Japan, 634-8522
        • Nara Medical University
    • Fukuoka
      • Kitakyushu-city, Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
    • Minato-ku
      • Nishi-Shinbashi, Minato-ku, Japan
        • The Jikei University Hospital
  • United States
    • California
      • Mountain View, California, United States, 94040
        • El Camino Hospital
      • Oceanside, California, United States, 92056
        • Tri-City Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Hospital and Clinics
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Memorial Center
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32216
        • Memorial -- Jacksonville
      • Miami, Florida, United States, 33176
        • Baptist Cardiac & Vascular Institute
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF St. Francis Medical Center
      • Springfield, Illinois, United States, 62702
        • Prairie Heart
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital
      • Indianapolis, Indiana, United States, 46290
        • The Care Group
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Christus St. Patrick Hospital
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Research Center
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital Kansas
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10016
        • NYU Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital
      • New York, New York, United States, 10025
        • St. Luke's Roosevelt Hospital Center
      • New York, New York, United States, 10075
        • Lenox Hill
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43214
        • MidWest Cardiology Research Foundation
      • Elyria, Ohio, United States, 44035
        • EMH Regional Medical Center
      • Toledo, Ohio, United States, 43614
        • University of Toledo University Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Pinnacle Health Harrisburg
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 92904
        • South Carolina Heart Center
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Peripheral Vascular Associates (PVA)
    • Utah
      • Murray, Utah, United States, 84107
        • LDS
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has signed and dated the informed consent.
  • Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
  • Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
  • Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
  • Patient has a resting Ankle Brachial Index (ABI) <0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a Toe Brachial Index (TBI) <0.8.
  • Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
  • Patient agrees to return for x-rays at 6 and 12 months.
  • Patient agrees to return for angiography at 12 months.
  • Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.

Exclusion Criteria:

  • Patient is pregnant or breast-feeding.
  • Patient is simultaneously participating in another investigational drug or device study.
  • Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
  • Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
  • Patient has had previous stenting of target vessel.
  • Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
  • Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
  • Patient lacks at least one patent vessel of runoff with <50% stenosis throughout its course.
  • Patient has untreated angiographically-evident thrombus in the target lesion.

[Additional criteria may apply.]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Zilver® PTX™ Drug Eluting Vascular Stent
Device: Zilver® PTX™ Drug Eluting Vascular Stent
Stenting of the Superfemoropopliteal Artery
Active Comparator: 2
Angioplasty
Procedure: Angioplasty
Angioplasty of the Superfemoropopliteal Artery
Other Names:
  • Balloon
  • PTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival Rate
Time Frame: 12 months

Event-free survival is defined as freedom from the major adverse events of death, target lesion revascularization, target limb ischemia requiring surgical intervention (bypass or amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection requiring surgery), and from worsening of the Rutherford classification by 2 classes or to class 5 or 6.

Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free survival is based on Per-Protocol analysis where only patients who were treated according to their initial randomization are counted.
12 months
Primary Patency
Time Frame: 12 months
Primary patency is defined as a Peak systolic velocity (PSV) ratio < 2.0 or angiographic percent diameter stenosis < 50%.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Collaborators

William Cook Europe
MED Institute, Incorporated
Cook Japan Incorporated

Investigators

  • Principal Investigator: Michael Dake, M.D., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 11, 2005

First Submitted That Met QC Criteria

July 11, 2005

First Posted (Estimate)

July 18, 2005

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

July 21, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-026
  • PS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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