Status:
COMPLETED
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
JOTEC Company
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00147979
Start Date
April 1 2004
End Date
August 1 2013
Last Update
December 5 2014
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000