NCT06494631

Xeltis Hemodialysis Access Graft (aXess) US Study

Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Xeltis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Xeltis Hemodialysis Access (aXess) graft	The aXess graft is a sterile, restorative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Timeline

• Start date: 2024-11-11
• Primary completion: 2028-01-01
• Completion: 2032-01-01
• First posted: 2024-07-10
• Last updated: 2025-09-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study