Trials / Active Not Recruiting
Active Not RecruitingNCT05473299
Xeltis Hemodialysis Access Graft: aXess Pivotal Study
Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Xeltis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xeltis Hemodialysis Access (aXess) graft | The aXess graft is a sterile, regenerative 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
- 2022-11-04
- Primary completion
- 2025-06-23
- Completion
- 2029-12-31
- First posted
- 2022-07-25
- Last updated
- 2025-07-18
Locations
22 sites across 9 countries: Belgium, Germany, Greece, Italy, Latvia, Poland, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05473299. Inclusion in this directory is not an endorsement.