NCT06951685

Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit Early Feasibility Study

Prospective, Non-randomized, Early Feasibility Clinical Study to Assess the Feasibility of the Novel Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Xeltis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Artery Occlusive Disease

Interventions

Type	Name	Description
DEVICE	Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit	The 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.

Timeline

• Start date: 2025-05-02
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2025-04-30
• Last updated: 2025-07-15

Locations

1 site across 1 country: Costa Rica