Clinical trial NCT06951685: Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
Official title: Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Occlusive Disease
Lead sponsor: Xeltis
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single arm, non-randomized early feasibility study to evaluate the preliminary safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective above-knee femoral popliteal bypass surgery.


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)

Primary outcomes:
measure: Primary patency rate
timeFrame: 12 months
measure: Freedom from device-related SAE
timeFrame: Day 1, 1, 6 and 12 months
Secondary outcomes:
measure: Implantation success rate
timeFrame: Day 1
measure: Freedom from Major Bleeding events
timeFrame: Day 1, 1 and 6 months
measure: Patency (primary, primary assisted, and secondary) rates
timeFrame: 6, 12, 24, and 36 months
measure: Freedom from device-related SAE
timeFrame: 24 and 36 months
measure: Rate of wound/graft infections
timeFrame: 1, 6, 12, 24, and 36 months
measure: Freedom from Major Amputations
timeFrame: 1, 6, 12, 24, and 36 months
measure: Freedom from all-cause mortality
timeFrame: 1, 6, 12, 24, and 36 months
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Centro de Investigación y Manejo del Cáncer (CIMCA)
Study officials:
References: