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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
XPAD conduit
DeviceThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: XPADExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary patency rate
Primary patency defined as the interval between conduit implantation and the first intervention to maintain or restore patency
Time frame
12 months post-implant2
Freedom from device-related SAE
Time frame
Day 1, 30 days, 6 months, and 12 months post-implantSecondary outcomes
1
Implantation success rate
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.
Time frame
Day 12
Freedom from Major Bleeding events
Major Bleeding defined as type 3, 4 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) classifications
Time frame
Day 1, 30 days and 6 months post-implant3
Patency (primary, primary assisted, and secondary) rates
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).
Time frame
6, 12, 24, 36, 48 and 60 months post-implant4
Freedom from device-related SAE
Time frame
24, 36, 48 and 60 months post-implantLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: