Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE (REPLACE)

This is an interventional other trial for Ischemia Lesions focused on measuring vascular prostheses, heparin, ischemia lesions, vascular, critical limb ischemia lesions Read More

Inclusion Criteria:

• 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 Criteria:

• 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