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NOT YET RECRUITING

NCT07716020

XPAD European Feasibility Study

Sponsor: Xeltis

View on ClinicalTrials.gov

Summary

A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery.

Official title: Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12

Completion Date

2032-12

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Peripheral Arterial Disease

Interventions

DEVICE

XPAD conduit

The XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 33cm length and 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The XPAD conduit is in a straight configuration and may be implanted in the lower limb for elective bypass surgery.

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)