Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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 device.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Age ≥18 years at time of Informed Consent Form (ICF) signature.

• Willingness of the patient to adhere to institutional standard of care follow-up.

• Informed Consent Form (ICF) is signed by the patient.

• 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.

• The patient has a reasonable expectation of remaining on hemodialysis for 12 months.

Locations
Other Locations
Germany
Evangelisches Klinikum Bethel (EvKB)
RECRUITING
Bielefeld
Ev. DiakonissenKrankenhaus Leipzigemeinnützige
RECRUITING
Leipzig
Italy
ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi
RECRUITING
Varese
United Kingdom
North Bristol NHS Trust Southmead Hospital
RECRUITING
Bristol
King's College Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Elisabetta Ferro
eferro@wlgore.com
+39 3486244749
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2027-10-27
Participants
Target number of participants: 72
Treatments
ESRD patients that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.
Patient population - patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.~Registry subject population - those patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft meeting the inclusion and exclusion criteria will be eligible for screening for participation in this registry.~The registry has been designed with broad eligibility criteria to capture real-world GORE® ACUSEAL Vascular Graft use, for which the device is intended to be implanted. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted.~No vulnerable populations are included in this registry.
Related Therapeutic Areas
Sponsors
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov