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Completed

NCT Number: NCT00147979

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

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

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bridging by PTFE with bounded heparin

Device

Bridging by PTFE with bounded heparin

Bridging by PTFE without bounded heparin

Device

Bridging by PTFE without bounded heparin

Primary outcomes

  1. Primary patency after 2 years

    Time frame: after 2 years

Secondary outcomes

  1. Secondary patency

    Time frame: after 2 years

  2. Limb salvage

    Time frame: after 2 years

  3. Mortality

    Time frame: after 2 years

  4. Re-intervention

    Time frame: after 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • JOTEC Company

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2013
First posted
Sep 7, 2005
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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