aXess Pivotal Study v 1.0
Research type
Research Study
Full title
Prospective, non-randomized pivotal clinical study to assess the safety and performance of the Xeltis Hemodialysis Access graft: aXess Pivotal study.
IRAS ID
318276
Contact name
David Kingsmore
Contact email
Sponsor organisation
Xeltis B.V.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-22-06-039802, Eudamed
Duration of Study in the UK
6 years, 2 months, 17 days
Research summary
This study is a single arm, non-randomized pivotal medical device study. Patients that will participate are diagnosed with end-stage renal disease who plan to undergo hemodialysis in the first 6 months after access creation. The dialysis treatment requires a tube to be placed in the arm, called a hemodialysis access graft, needed for placing needles during the dialysis sessions. This study tests a new medical device that is used to create an access for dialysis, called the Xeltis hemodialysis access (aXess) graft. The reason for the study is to show that the graft is safe, works well, and is reliable. The idea is that this new device will replace the use of patients’ own vessels when making a dialysis fistula, or use of an access graft that is made of different material. Infections and blood clots occur often with the access grafts that are currently used, and this means that those grafts often must be removed and replaced in patients. The aXess graft wants to avoid these problems so that the graft can be used for a longer period. It is an artificial access graft made of a very special material called a supramolecular polymer. The polymer has metal (nitinol) inside its layers. The metal looks like a mesh tube inside the polymer. The graft is a home for the patient’s own blood cells that will grow into the graft structure, and the polymer will be absorbed over time. The patient’s body has grown the new vessel, and the metal structure, which will be covered by cells, will remain as a completely working vessel. After enrolment in the study, the aXess device will be implanted, and the subjects will be followed for 5 years. All tests and visits are similar to standard of care.
REC name
West of Scotland REC 4
REC reference
23/WS/0112
Date of REC Opinion
11 Sep 2023
REC opinion
Further Information Favourable Opinion