Zilver PTX Delivery System

January 29, 2016 updated by: Cook Group Incorporated

Zilver Paclitaxel(PTX) Thumbwheel Delivery System

The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Australia
      • Frankston, Australia, VIC 3199
        • Frankston Hospital
      • Woolloongabba, Australia, QLD 4102
        • Princess Alexandra Hospital
  • Germany
      • Bad Krozingen, Germany, D-79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3248
        • Waikato Hospital
      • Wellington, New Zealand, 3248
        • Wellington 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 symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
  • Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

  • Patient is < 18 years of age
  • Patient unable to complete required follow-up assessments
  • Patient unwilling to sign and date the informed consent
  • Simultaneous participation in another investigational drug or device study
  • Pregnant, breastfeeding or planning to become pregnant in the next 5 years
  • Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug Eluting Stent
Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent
Device: Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Percent Change in Stent Length Upon Deployment
Time Frame: Immediately following completion of the stent placement procedure
Immediately following completion of the stent placement procedure

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Andrew Holden, MD, Auckland District Health Board

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

September 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-14

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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