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

G

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

NCT00147979
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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

596 participants in 2 patient groups

1
Experimental group
Description:
PTFE with bounded heparin
Treatment:
Device: Bridging by PTFE with bounded heparin
2
Active Comparator group
Description:
PTFE without bounded heparin
Treatment:
Device: Bridging by PTFE without bounded heparin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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