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.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-02; most recent amendment 2025-08-29.
Status change: Not Yet Recruiting → Enrolling by Invitation2024-12-20