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

Inclusion criteria

• Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
• Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease and TASC C or D lesions. Rutherford grade 5 may be included with a wound, ischemia and foot infection (WiFi) classification of up to grade 2, provided there are two outflow vessels with at least one reaching the pedal arch
• At least 18 years of age at screening
• Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
• Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
• Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography
• Life expectancy of at least 24 months

Exclusion criteria

• Subject requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
• Presence or history of bypass in the diseased limb
• Subject requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts
• Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)
• History of acute arterial occlusion requiring an emergent intervention
• Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
• Previous renal transplant
• Uncontrolled arterial hypertension (BP >200 mmHg) at 2 successive readings
• Uncontrolled or poorly controlled diabetes
• Abnormal blood values that could influence patient recovery and or/ graft hemostasis
• 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
• Any active local or systemic infection
• Known heparin-induced thrombocytopenia
• Known active bleeding disorder and/or any coagulopathy or thromboembolic disease
• Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically
• Previous enrolment in this study
• Subject is participating in another study
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• 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:

• Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)