Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access(AVG22-09)
Research type
Research Study
Full title
Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
IRAS ID
328593
Contact name
Shakeeb Khan
Contact email
Sponsor organisation
W.L. Gore and Associates Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
A total of 72 subjects will be implanted in this registry with a limit of 25 subjects implanted per site. Data collected will be representative of real-world, clinical use. Real world clinical use data are integral for Gore combined with data from long-term clinical investigations and reports from medical literature, to perform continuing assessments of device safety and performance in addition to any long-term clinical investigations, as well as reports in medical journals. To ensure that registry data are representative of real-world use, the registry will employ broad inclusion / exclusion criteria which assure its observational nature.
Patients may be enrolled into the registry provided all inclusion and no exclusion criteria are met, and that Informed Consent Form (ICF) has been obtained. Expected time to complete enrollment is 24 months. Subjects will be evaluated through hospital discharge and return for follow-up visits per site standard of care. Safety and performance data of GORE® ACUSEAL Vascular Graft will be measured at 6 months, 12 months, and 24 months post treatment, if available per local standard of care. Expected duration of data analysis and Close-out is 12 months. Total estimated duration of the registry is 60 months.
Bias will be controlled by strict adherence to this protocol. Sites will be monitored for compliance with the protocol, including subject eligibility criteria.REC name
HSC REC B
REC reference
23/NI/0073
Date of REC Opinion
19 Jun 2023
REC opinion
Further Information Favourable Opinion