Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
Xeltis
6 participants
May 2, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria20
- 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
- \. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)
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Interventions
The XPAD bypass conduit is a sterile, restorative biodegradable polymer-based vascular graft, 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 above the knee for elective femoral popliteal bypass surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06951685