Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study
ConditionPeripheral Artery Occlusive Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXeltis
About this trial
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
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov