XPAD European Feasibility Study

Inclusion Criteria:

1. Participants with peripheral artery occlusion who require elective lower-limb bypass surgery
2. Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.
3. At least 18 years of age at screening
4. Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
5. Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
6. Participant has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
7. Life expectancy of at least 24 months

Exclusion Criteria:

1. Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
2. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
3. History of acute arterial occlusion requiring an emergent intervention within the last 12 months
4. Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
5. Previous renal transplant
6. Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
7. Uncontrolled or poorly controlled diabetes
8. Abnormal blood values that could influence participant recovery and or/ graft hemostasis
9. 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
10. Any active local or systemic infection
11. Known heparin- induced thrombocytopenia, active bleeding disorder and/or any coagulopathy or thromboembolic disease
12. Allergies to study device (nitinol) or agents/medication, such as contrast agents, aspirin or NOACs, that can't be controlled medically
13. Previous enrolment in this study
14. Participant is participating in another study
15. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
16. Any other condition which, in the judgement of the investigator would preclude adequate 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 smaller than anticipated; severe calcification)