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

Ghent University Hospital (UZ)

Status

Completed

Conditions

Peripheral Vascular Diseases

Treatments

Device: Bridging by PTFE without bounded heparin

Device: Bridging by PTFE with bounded heparin

Study type

Interventional

Funder types

Other

Identifiers

2004/042

Details and patient eligibility

About

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

Full 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

Enrollment

596 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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