XPAD European Feasibility Study

Sponsor
Xeltis
Study ID
NCT07716020
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XPAD conduit — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2032

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: XPAD

Primary Outcome Measure

Primary patency rate [ Time Frame: 12 months post-implant ]

Central Contacts

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