Safety and performance evaluation of the av-Guardian Vascular Access System for hemodialysis patients

• Register: ANZCTR
• Last refreshed on: 4 May 2020
• Main ID: ACTRN12617000501347
• Date of registration: 06/04/2017
• Prospective Registration: No
• Primary sponsor: Advent Access Pte Ltd
• Public title: Safety and performance evaluation of the av-Guardian Vascular Access System for hemodialysis patients
• Scientific title: Non-randomized safety and performance evaluation of the av-Guardian Vascular Access System in 6 chronic hemodialysis patients
• Date of first enrolment: 28/03/2016
• Target sample size: 6
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000501347.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand, Singapore

Contacts

• Name: A/Prof Lina Choong

• Name: Dr Ivon Septriyana

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Established chronic haemodialysis subjects.
3. Subjects with an established AVF that is:
a. Successfully in use for >= 12 dialysis sessions.
b. With a flow of > 600 cc/min (if the flow is <= 600 cc/min, an approval from the sponsor’s medical representative is mandatory).
c. Located between 4mm and 8mm under the skin.
d. With minimum diameter of >= 5mm at cannulation segment.
e. Subjects with an estimated life expectancy of >= 1 year from the date of signature on the informed consent.
Exclusion criteria: 1. Subjects who are not able to comply with the clinical investigation follow-up or other clinical investigation requirements.
2. Subjects involved concurrently in another drug or device clinical investigation that may potentially clinically interfere with the endpoints of this clinical investigation.
3. Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation.
4. Subjects who underwent a surgical revision on the target AVF involving placement of a prosthetic graft.
5. Subjects with active systemic infection.
6. Subjects on immunosuppression medication.
7. Subjects with non-treated malignant disease.
8. Subjects with valvular heart disease.
9. Subjects with pre-existing allergies such as titanium allergy or known allergy to any component part of the investigational device.
10. Subjects with skin anomalies such as skin infections, skin disorders, hypersensitive skin at the potential target implantation site.
11. Subjects with uncontrolled diabetes mellitus
12. Subjects with uncontrolled coagulation disorders.
13. Obese subjects (BMI > 35).
14. Subjects with history of more than one intervention per year on the target AV-fistula.
15. Subjects with recent intervention on the target AV-fistula < 6 months.

Age minimum: 21 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

vascular access to arterio-venous fistula (AVF) for hemodialysis ;chronic kidney disease;
vascular access to arterio-venous fistula (AVF) for hemodialysis
chronic kidney disease

Renal and Urogenital - Kidney disease

Intervention(s)

The av-Guardian device is a small medical grade titanium implant, which will be implanted in the subcutaneous space above the fistula and under the skin by a vascular surgeon. [Procedure phase] Implantation of the device will be performed using the deployment tool, a spoon-like instrument on which the av-Guardian device sits and is used to deliver the device into the subcutaneous space through a small incision. Two devices will be implanted per patient, one at the arterio side of the fistula (A site for suction of blood into the dialysis machine), and the other at the venous side (V site for return of blood from the dialysis machine). The procedure is minimally invasive, will take about 10 min. It will be done in the operating theatre.
[Healing Phase] 2-4 weeks post-implantation, the implanting vascular surgeon will check the implant for sufficient fibrosis and stability, to determine device readiness for cannulation.
[Cannulation Phase] After determination of device readiness by the vascular surgeon, the device will be used by trained cannulators such as renal nurses, nephrologist, interventionalist to guide the fistula needle for access to the AVF for hemodialysis, using a method that is similar to the buttonhole cannulation technique. Patients will be observed for cannulation through the device 3x a week, for 3 months from the first cannulation through the device. (total of 36 cannulations). Cannulation will be done at the designated trial dialysis centre.
[Long-term Follow-up Observational Phase] Upon completion of the 3 months post first cannulation follow-up, patients are entitled to continue using the device at their original dialysis centre, as they return to their routine dialysis treatment (pre-trial). They will also be asked if they are agreeable

Primary Outcome(s)

Safety of the implantation procedure, as determined by the change in access blood flow rate in the AVF from pre- to post- implantation, measured by transonic flow rate or ultrasound. [Baseline, and Immediately post-implantation
]

Successful cannulation of the AVF through the av-Guardian, as determined by the rate of successful vascular access allowing dialysis through the av-Guardian device by direct observation by a research nurse at each cannulation. .
[At cannulation 3 times a week for 3 months after first cannulation through the device (Follow-up cannulation phase).]

Safety of the device, as determined by the rate of successful hemodialysis session with or without cannulation using the av-Guardian through the target AVF by direct observation by a research nurse at the end of the dialysis session.[Post dialysis 3 times a week for about 3 weeks (up to a month) before cannulation through the device (Follow-up healing phase); and post dialysis 3 times a week for 3 months after first cannulation through the device (Follow-up cannulation phase), ]

Secondary Outcome(s)

av-Guardian aids in the successful creation of a needle track, as determined by the timepoint at which blunt needle puncture is reached by direct observation by a research nurse at each cannulation. .

[Assessed at cannulation 3 times a week until the a needle track is observed and a blunt needle is used successfully for the cannulation. ]

Monitoring of safety and effectiveness beyond study endpoints, as determined by observation of device related adverse events and, cannulation success and dialysis up to 36 months follow-up post first cannulation through the device. [Assessed at cannulation 3 times a week during dialysis, and for up to 36 months follow-up post first cannulation through the device. ]

Secondary ID(s)

NONE

Source(s) of Monetary Support

Advent Access Pte Ltd

Ethics review

Status: Approved
Approval date: 14/10/2015
Contact:

Singhealth Centralised Instituitional Review Board

Status: Approved
Approval date: 05/04/2017
Contact:

Southern Health and Disability Ethics Committee

Results

• Results available: Yes
• Date Posted: 11/04/2019
• Date Completed: 20/04/2020