Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

December 4, 2014 updated by: University Hospital, Ghent
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin.

Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

Study Type

Interventional

Enrollment (Actual)

596

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

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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:

  • Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene
  • Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm
  • Reasonable outflow arteria
  • Informed consent
  • Patient able to take part in all follow-up examinations

Exclusion Criteria:

  • Acute ischemia of the leg
  • Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery
  • < 18 years
  • Pregnancy
  • Recent heart attack (< 1 month)
  • Life expectancy less than 12 months
  • Known allergy to heparin
  • Known contrast allergy
  • Known bleeding or coagulation disorder

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PTFE with bounded heparin
Device: Bridging by PTFE with bounded heparin
Bridging by PTFE with bounded heparin
Active Comparator: 2
PTFE without bounded heparin
Device: Bridging by PTFE without bounded heparin
Bridging by PTFE without bounded heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary patency after 2 years
Time Frame: after 2 years
after 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary patency
Time Frame: after 2 years
after 2 years
Limb salvage
Time Frame: after 2 years
after 2 years
Mortality
Time Frame: after 2 years
after 2 years
Re-intervention
Time Frame: after 2 years
after 2 years

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

JOTEC Company

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.

Helpful Links

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

April 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004/042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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