Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
NCT ID: NCT00147979
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
596 participants
INTERVENTIONAL
2004-04-30
2013-08-31
Brief Summary
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Detailed Description
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Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
PTFE with bounded heparin
Bridging by PTFE with bounded heparin
Bridging by PTFE with bounded heparin
2
PTFE without bounded heparin
Bridging by PTFE without bounded heparin
Bridging by PTFE without bounded heparin
Interventions
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Bridging by PTFE with bounded heparin
Bridging by PTFE with bounded heparin
Bridging by PTFE without bounded heparin
Bridging by PTFE without bounded heparin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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JOTEC Company
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Frank Vermassen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Website University Hospital Ghent
Other Identifiers
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2004/042
Identifier Type: -
Identifier Source: org_study_id