ClinicaliQ Trial Snapshot
- Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access — Recruiting • Infectious Disease • NCT05846581.
- What is being tested: Safety and performance of GORE® ACUSEAL Vascular Graft, a synthetic vascular access device for haemodialysis in patients with end-stage renal disease (ESRD), evaluated through an observational registry study.
- Patient eligibility overview: CKD patients with ESRD requiring haemodialysis who are candidates for vascular graft placement as an arteriovenous access, encompassing those who may be unsuitable for native fistula creation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: * Safety: Freedom from device-related infection adverse events at 24 months from device implant * Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the…
Eligibility Snapshot
- : 1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access. 2. Age ≥18 years at time of Informed Consent Form (ICF) signature. 3. Willingness of the patient to adhere to institutional standard of care follow-up. 4. Informed Consent Form (ICF) is signed by the patient. 5. The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device. 6. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.