Zilver PTX Drug-Eluting Peripheral Stent Study

December 29, 2015 updated by: Cook Group Incorporated

Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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
      • Berlin, Germany, 10365
        • Evangelische Krankenhaus Königin Elisabeth Herzberge
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A.ö.R.
  • Switzerland
      • Berne, Switzerland, 3010
        • Inselspital, Universitätsspital Bern

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:

  • One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
  • Reference vessel diameter of 4 - 9 mm
  • Rutherford category ≥ 2
  • Resting ankle brachial index < 0.9

Exclusion Criteria:

  • Prior stent in the study vessel
  • Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
  • Lacks at least one patent runoff vessel
  • Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

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: Longer Stents
Device: Longer Zilver PTX Stents
Treatment with at least one 100 mm or longer Zilver PTX stent
Experimental: Shorter Stents
Device: Shorter Zilver PTX Stents
Treatment with Zilver PTX stents 80 mm or shorter only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Stent Length Upon Deployment
Time Frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Prof. Dr. med. Jens Ricke, Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine

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

May 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-003

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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