An interventional study of XPAD conduit in Peripheral Arterial Disease, sponsored by Xeltis. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Xeltis · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Intra-operative exclusion criteria:
1. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)
Device: XPAD conduit
The 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.
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-implant
Freedom from device-related SAE
Time frame: Day 1, 30 days, 6 months, and 12 months post-implant
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 1
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-implant
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-implant
Freedom from device-related SAE
Time frame: 24, 36, 48 and 60 months post-implant
Rate of wound/conduit infections
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months post-implant
Freedom from Major Amputations
Major Amputation defined as any amputation that results in limb shortening
Time frame: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
Freedom from all-cause mortality
Time frame: 30 days, 6, 12, 24, 36, 48, and 60 months post-implant
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Xeltis