Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study

Exclusion Criteria

• •1. Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
• •2. Presence or history of bypass in the diseased limb
• •3. Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
• •4. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
• •5. History of acute arterial occlusion requiring an emergent intervention
• •6. Severe chronic renal insufficiency (serum creatinine \>2.5 mg/dL) or undergoing hemodialysis
• •7. Previous renal transplant
• •8. Uncontrolled arterial hypertension (BP \>200 mmHg) at 2 successive readings
• •9. Uncontrolled or poorly controlled diabetes
• •10. Abnormal blood values that could influence patient recovery and or/ graft hemostasis
• •11. Reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \>1.5 or prothrombin time (PT) \>18 seconds
• •12. Any active local or systemic infection
• •13. Known heparin-induced thrombocytopenia
• •14. Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
• •15. Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
• •16. Previous enrolment in this study
• •17. Subject is participating in another study
• •18. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• •19. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit
• •1\. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)