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

Launched by XELTIS · Apr 22, 2025

Keywords

ClinConnect Summary

The Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study is a clinical trial designed to test a new type of medical device called the XPAD conduit. This study aims to see how safe and effective this conduit is for patients suffering from Peripheral Artery Occlusive Disease (PAOD) who need surgery to improve blood flow in their legs. The trial is currently recruiting participants who are between the ages of 65 and 74 and have specific types of artery blockages that require a particular kind of bypass surgery.

To be eligible for this study, participants must have a blockage in the femoral artery and be scheduled for elective above-knee femoral popliteal bypass surgery. They should be at least 18 years old and have a suitable blood vessel structure, which will be checked through imaging tests. Those who join the study will receive the XPAD conduit during their surgery and will need to agree to follow-up appointments to monitor their recovery. It’s important to note that there are certain health conditions that may exclude someone from participating, like recent heart problems or severe kidney issues. Overall, this study represents an exciting opportunity to learn more about a new treatment option for improving blood flow in patients with PAOD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects with femoral artery occlusion who require elective above-knee femoral popliteal bypass surgery
• • 2. 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
• • 3. At least 18 years of age at screening
• • 4. Suitable anatomy (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
• • 5. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
• • 6. Patient 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. 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
• Intra-operative exclusion criteria:
• • 1. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)