Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Not Applicable
Completed
- Conditions
- Peripheral Vascular Diseases
- Registration Number
- NCT00147979
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 596
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary patency after 2 years after 2 years
- Secondary Outcome Measures
Name Time Method Secondary patency after 2 years Limb salvage after 2 years Mortality after 2 years Re-intervention after 2 years
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium
University Hospital Ghent🇧🇪Ghent, Belgium