Status:
COMPLETED
Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
W.L.Gore & Associates
Conditions:
Ischemia Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair. A g...
Detailed Description
Patient inclusion in this study will be proposed 60 to 1-days period preceding the surgical procedure. The patient will be randomized in the crude PTFE or in the Propaten groups. Regarding the interve...
Eligibility Criteria
Inclusion
- Patient ≥18 years
- 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
- No atheromatous disease
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2024
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03430076
Start Date
February 13 2018
End Date
January 29 2024
Last Update
April 5 2024
Active Locations (21)
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1
Angers University Hospital
Angers, France, 49 933
2
Besançon University Hospital
Besançon, France, 25 000
3
Bordeaux University Hospital - Hôpital Pellegrin
Bordeaux, France, 33000
4
Ambroise Paré university Hospital
Boulogne-Billancourt, France, 92100