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 — 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.
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
- Sandra Kohler+31 (0) 6 55 55 57 14
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