Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
The patient currently has a known or suspected systemic infection.
The patient is pregnant or breastfeeding.
The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device.
The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GORE® ACUSEAL Vascular Graft
DeviceThe device placement will be performed according to each participating site's standard practice. No specific procedures are required by the protocol. At the time of the GORE® ACUSEAL Vascular Grafts implantation, procedural and adverse event information will be collected.
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: ESRD patients that require hemodialysis access through the GORE® ACUSEAL Vascular Graft.1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant.
Events will be computed as follows: 1. All subjects who had a registry device related AE with an Infection MedDRA code within 730 days from device implant will be tabulated as 'Not Free from Infection'. 2. All subjects who completed the registry and were infection free at 24 months from the registry procedure will be considered free from device related infection. All relevant infection MedDRA terms will be agreed upon by the Office of Medical Affairs within Gore. This endpoint will be treated as a patient-based binomial proportion, and no formal hypothesis will be tested. A Kaplan Meir analysis will also be done to account for censoring.
Time frame
24 months from device implant2
Primary Performance Endpoint. Secondary Patency at 24 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.
Events will be computed as follows: 1. All subjects who have an abandonment or explant of the registry graft within 730 days will have lost secondary patency. The date will be noted on the discontinuation form. 2. All subjects who completed the registry within 730 days without a graft abandonment will be considered patent. 3. If a subject did not complete the registry for a reason other than graft abandonment or explant, they will be censored. A Kaplan Meir analysis will be done to account for censoring.
Time frame
24 months from device implantSecondary outcomes
1
Percentage of GORE® ACUSEAL Vascular Grafts cannulated within 1, 2, 3, 7, and 14 days from device implant.
The percentage of GORE® ACUSEAL Grafts cannulated within 24, 48,72,168, and 336 hours post device implant will be computed as follows: 1\. The hours from end time of procedure to the first successful hemodialysis session performed through the GORE® ACUSEAL Graft will be recorded per subject. This endpoint will be treated as a patient-based binomial proportion and will be summarized as percent with a 95% confidence interval.
Time frame
Cannulation within 1, 2, 3, 7 and 14 days from device implant.2
Percentage of Subjects free from bleeding events through 6, 12, and 24 months from device implant.
1. All subjects experiencing an adverse event classified as bleeding prior to the end of the designated window will be counted as having a bleeding event within that interval. 2. Subjects not experiencing case 1, who have had a follow-up visit after the beginning of the designated interval, are declared as having no bleeding event. 3. All subjects not experiencing case 1 or 2 will not be included in computations for the corresponding interval. A Kaplan Meir analysis will be done to account for censoring.
Time frame
6, 12, and 24 months from device implant3
Secondary Patency at 6 and 12 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.
Events will be computed as follows: 1. All subjects who have an abandonment or explant of the registry graft within 730 days will have lost secondary patency. The date will be noted on the discontinuation form. 2. All subjects who completed the registry within 730 days without a graft abandonment will be considered patent. 3. If a subject did not complete the registry for a reason other than graft abandonment or explant, they will be censored. A Kaplan Meir analysis will be done to account for censoring.
Time frame
6 and 12 months from device implant.4
Primary patency at 6, 12 and 24 months from device implant. Time interval of uninterrupted patency from device implant to the next access thrombosis or intervention.
Primary Patency will be calculated at 6 months, 12 months, and 24 months from device implant, and will use the following decision rules: 1. Subjects who have a repeat intervention, thrombosis event, abandonment or explant of the registry graft prior to the end of the analysis window will have lost patency. 2. Subjects who have not experienced case 1, and had a follow-up visit within the desired analysis window are considered patent. 3. All other subjects will be censored. A Kaplan Meir analysis will be done to account for censoring.
Time frame
6, 12 and 24 months from device implant.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov