Peripheral Arterial Disease
Conditions
Brief 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.
Interventions
DEVICEXPAD 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.
Sponsors
Xeltis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate | 12 months post-implant | Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency |
| Freedom from device-related SAE | Day 1, 30 days, 6 months, and 12 months post-implant | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation success rate | Day 1 | Implantation success defined as a technically successful XPAD conduit implantation in the planned configuration, free from kinking and tension in the anastomoses, and a patent XPAD conduit at the moment of discharge. |
| Freedom from Major Bleeding events | Day 1, 30 days and 6 months post-implant | Major Bleeding defined as type 3, 4 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) classifications |
| Patency (primary, primary assisted, and secondary) rates | 6, 12, 24, 36, 48 and 60 months post-implant | Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency. Assisted primary patency defined as the interval between conduit implantation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the conduit. Secondary patency defined as the interval between conduit implantation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the conduit, including occurrence of a censored event (death, change of modality, loss of follow-up). |
| Freedom from device-related SAE | 24, 36, 48 and 60 months post-implant | — |
| Rate of wound/conduit infections | 30 days, 6, 12, 24, 36, 48 and 60 months post-implant | — |
| Freedom from Major Amputations | 30 days, 6, 12, 24, 36, 48, and 60 months post-implant | Major Amputation defined as any amputation that results in limb shortening |
| Freedom from all-cause mortality | 30 days, 6, 12, 24, 36, 48, and 60 months post-implant | — |
Contacts
CONTACTSandra Kohler
Outcome results
None listed