Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
NCT ID: NCT03430076
Last Updated: 2024-04-05
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
228 participants
INTERVENTIONAL
2018-02-13
2024-01-29
Brief Summary
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Recently, PTFE with heparin-bound to the luminal surface (Hb-PTFE) significantly reduced the overall risk of primary graft failure by 37%, in particular, risk reduction was 50% in femoropopliteal bypass cases in cases with critical ischemia (58% Primary patency for crude ePTFE versus 80% primary patency for PROPATEN at 1 year follow-up) (Lindholt, et. al. 2011).
Additionally, a weighted average from the literature suggests a 76% primary patency for below knee bypasses performed with PROPATEN at one year follow-up, whereas a published meta-analysis suggests a 59% primary patency for below knee crude ePTFE at one year follow-up. At two year follow-up using the same approach, the average primary patency for PROPATEN was 67% versus 43% for standard ePTFE.
The aim of this study is to assess PTFE with heparin-bound to the luminal surface as an alternative to crude PTFE in absence of good venous conduit in patients with CLI.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Revascularization by (Propaten)®
Revascularization by PTFE with heparin bonded luminal surface (Propaten)®
revascularization
open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.
Propaten®
Propaten®
Revascularization by Crude PTFE
revascularization
open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.
Crude PTFE
Crude PTFE
Interventions
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revascularization
open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.
Propaten®
Propaten®
Crude PTFE
Crude PTFE
Eligibility Criteria
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Inclusion Criteria
* Patient presented critical limb ischemia (Rutherford classification: 4-6)
* Indication of below the knee bypass with an artificial graft
* Absence of an suitable autologous vein
* Patient is affiliated to the Social Security or equivalent system
* Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
* Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
Exclusion Criteria
* Female of child bearing potential
* Patient has a history of coagulopathy or will refuse blood transfusions
* Patient is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
* Severe concomitant disease with life expectation \< one year
* Known allergy to heparin
* Indication for ipsilateral major amputation
* Patient is not able to give informed consent
* Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially suitable since then, are not considered investigational trials
* In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yann Gouëffic, Pr
Role: PRINCIPAL_INVESTIGATOR
Saint Joseph Hospital Paris
Locations
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Angers University Hospital
Angers, , France
Besançon University Hospital
Besançon, , France
Bordeaux University Hospital - Hôpital Pellegrin
Bordeaux, , France
Ambroise Paré university Hospital
Boulogne-Billancourt, , France
Brest University Hospital
Brest, , France
Clermont-Ferrand University Hospital
Clermont-Ferrand, , France
Dijon University Hospital
Dijon, , France
Lille University Hospital
Lille, , France
Lyon University Hospital - Hopital Edouard Herriot
Lyon, , France
Timone hospital
Marseille, , France
Nancy University Hospital
Nancy, , France
Nantes University Hospital
Nantes, , France
Hopital Pasteur
Nice, , France
Saint Joseph Hospital
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Bichat Hospital
Paris, , France
Poitiers University Hospital
Poitiers, , France
Reims university Hospital
Reims, , France
Saint Etienne University Hospital
Saint-Etienne, , France
Nouvel Hopital Civil
Strasbourg, , France
Valenciennes University Hospital
Valenciennes, , France
Countries
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Other Identifiers
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RC17_0205
Identifier Type: -
Identifier Source: org_study_id
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