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

Inclusion Criteria:

1. Subjects with femoral artery occlusion who require elective above-knee femoralpopliteal bypass surgery

2. Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or Dlesions. Rutherford grade 5 may be included with a wound, ischemia and footinfection (WiFi) classification of up to grade 2, provided there are two outflowvessels with at least one reaching the pedal arch

3. At least 18 years of age at screening

4. Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previousangiogram assessed up to 90 days prior to baseline)

5. Patient has been informed of the nature of the study, agrees to its provisions, andhas provided written informed consent

6. Patient has been informed and agrees to pre- and post-procedure follow-up, includingfollow-up angiography

7. Life expectancy of at least 24 months

Exclusion Criteria:

1. Subject requires, or is scheduled for, a cardiac surgical procedure or a differentvascular 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 thatrequire use of additional vascular grafts

4. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence ofprior 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 undergoinghemodialysis

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 serumbilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18seconds

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 oraspirin, 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 adequatecontraceptives

19. Any other condition which, in the judgement of the investigator would precludeadequate evaluation for the safety and performance of the study conduit

Intra-operative exclusion criteria:

1. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smallerthan anticipated; severe calcification)