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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit
DeviceThe 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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: XPAD Bypass ConduitExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary patency rate
Primary patency: Defined as the interval between graft implantation and the first intervention to maintain or restore patency
Time frame
12 months2
Freedom from device-related SAE
Time frame
Day 1, 1, 6 and 12 monthsSecondary 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, 1 and 6 months3
Patency (primary, primary assisted, and secondary) rates
Primary patency: Defined as the interval between graft implantation and the first intervention to maintain or restore patency. Assisted primary patency: Defined as the interval between graft implantation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality the graft. Secondary patency: Defined as the interval between graft implantation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the graft, including occurrence of a censored event (death, change of modality, loss of follow-up)
Time frame
6, 12, 24, and 36 months4
Freedom from device-related SAE
Time frame
24 and 36 months Source ClinicalTrials.gov