Clinical trial NCT05846581: Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Official title: Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
End Stage Renal Disease on Dialysis
Keywords: Post-Market Clinical Follow-Up
Chronic Kidney Diseases
End Stage Renal Disease
Hemodialysis
vascular graft
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Detailed description: This is a European, Observational, Non-Interventional, Prospective, Non-Randomized, Single Arm, Multicenter, PMCF Registry to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. There is no comparator device.

The aim of study is to obtain real-world observational evidence about the use of the device.

The AVG 22-09 registry consists of End-Stage Renal Disease (ESRD) patients who require hemodialysis access through Vascular Graft per the evaluating physician.

A total of 72 subjects will be implanted in this registry with a limit of 25 subjects implanted per site.

The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. All patients must provide informed consent prior to any registry related procedures being performed and the patient is considered enrolled when informed consent is obtained.

The primary objective is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft in hemodialysis access for the treatment of Chronic Kidney Disease (CKD) in patients with End Stage Renal Disease (ESRD).

All patients who sign an informed consent will be considered enrolled and at the completion of study participation, subjects will be advised by their respective clinical centers on the appropriate follow up regimen to be followed but it is expected that the each implanted subject will be evaluated through hospital discharge and return for follow-up visits per site standard of care.

Each enrolled and implanted subject will be followed for 24 months.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

1. The patient currently has a known or suspected systemic infection.
2. The patient is pregnant or breastfeeding.
3. 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.
4. The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.
5. The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.
6. The patient has a known hypercoagulability or bleeding disorder.
7. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.
8. The patient is enrolled in an investigational study.
9. The patient has been previously enrolled in this registry.
10. The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).
11. The patient has life expectancy less than 2 years.

Primary outcomes:
measure: Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant.
timeFrame: 24 months from device implant
measure: 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.
timeFrame: 24 months from device implant
Secondary outcomes:
measure: Percentage of GORE® ACUSEAL Vascular Grafts cannulated within 1, 2, 3, 7, and 14 days from device implant.
timeFrame: Cannulation within 1, 2, 3, 7 and 14 days from device implant.
measure: Percentage of Subjects free from bleeding events through 6, 12, and 24 months from device implant.
timeFrame: 6, 12, and 24 months from device implant
measure: 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.
timeFrame: 6 and 12 months from device implant.
measure: 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.
timeFrame: 6, 12 and 24 months from device implant.
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel (EvKB)
city: Leipzig
country: Germany
facility: Ev. DiakonissenKrankenhaus Leipzigemeinnützige
city: Varese
country: Italy
facility: ASST-Settelaghi Ospedale di Circolo e Fondazione Macchi
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust Southmead Hospital
state: England
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: England
Study officials:
affiliation: University of Insubria (Italy)
name: Matteo Tozzi
role: PRINCIPAL_INVESTIGATOR
References: