XPAD European Feasibility Study
ConditionPeripheral Arterial Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXeltis
About this trial
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.
Eligibility criteria
Qualifiers
Participants with peripheral artery occlusion who require elective lower-limb bypass surgery
Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.
At least 18 years of age at screening
Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)
Disqualifiers
Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.
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 within the last 12 months
Severe chronic renal insufficiency (serum creatinine >2.5 mg/dL) or undergoing hemodialysis
Trial design
Treatments tested in this trial
- XPAD conduit
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov