Xeltis Hemodialysis Access Graft (aXess) US Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Xeltis
Study ID
NCT06494631
Status
Enrolling By Invitation

Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xeltis Hemodialysis Access (aXess) graft — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 11, 2024
Status verified
Dec 2024
Primary completion
Jan 31, 2028
Completion
Jan 31, 2032

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: aXess graft

Primary Outcome Measure

Secondary patency rate in survivors [ Time Frame: 12 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
AKDHC Medical Research Services, LLCPhoenixArizona85016-
AKDHC Medical Research Services, LLCTusconArizona85718-
Sarasota Memorial HospitalSarasotaFlorida34239-
Brigham and Women's HospitalBostonMassachusetts02115-
Greenwood Leflore HospitalGreenwoodMississippi38930-
Surgical Specialists of CharlotteCharlotteNorth Carolina28210-
Flow Vascular, Surgery Specialty Hospitals of AmericaPasadenaTexas77504-

Find similar trials in Phoenix, AZ

By research site
AKDHC Medical Research Services, LLC· Phoenix, AZAKDHC Medical Research Services, LLC· Tuscon, AZSarasota Memorial Hospital· Sarasota, FLBrigham and Women's Hospital· Boston, MAGreenwood Leflore Hospital· Greenwood, MSSurgical Specialists of Charlotte· Charlotte, NC

Related Studies