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NCT00147979 Clinical Trial

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

Peripheral Vascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147979
Other study ID # 2004/042
Secondary ID
Status Completed
Phase N/A
First received September 6, 2005
Last updated December 4, 2014
Start date April 2004
Est. completion date August 2013

Study information
Verified date December 2014
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 596
Est. completion date August 2013
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Bridging by PTFE with bounded heparin
Bridging by PTFE with bounded heparin
• Bridging by PTFE without bounded heparin
Bridging by PTFE without bounded heparin

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent JOTEC Company

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary patency after 2 years after 2 years No
Secondary Secondary patency after 2 years No
Secondary Limb salvage after 2 years No
Secondary Mortality after 2 years No
Secondary Re-intervention after 2 years No
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