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

University Hospital, Ghent1 site in 1 country596 target enrollmentApril 2004

ConditionsPeripheral Vascular Diseases

Overview

Phase: N/A
Intervention: Not specified
Conditions: Peripheral Vascular Diseases
Sponsor: University Hospital, Ghent
Enrollment: 596
Locations: 1
Primary Endpoint: Primary patency after 2 years
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

August 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

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