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

Not Applicable

Completed

• Conditions: Peripheral Vascular Diseases
• Interventions: Device: Bridging by PTFE with bounded heparin; Device: Bridging by PTFE without bounded heparin

• 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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Primary Completion: 2009-01
• Study Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

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

Arm && Interventions

Group	Intervention	Description
1	Bridging by PTFE with bounded heparin	PTFE with bounded heparin
2	Bridging by PTFE without bounded heparin	PTFE without bounded heparin

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