Safety and performance evaluation of the av-Guardian Vascular Access System for hemodialysis patients, including patients with deep AV- fistulas and self-cannulating patients

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 6

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 3.5mm and 10mm under the skin.
d. With minimum diameter of >= 5mm at cannulation segment.
4. 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 with active systemic infection.
5.Subjects on immunosuppression medication.
6.Subjects with non-treated malignant disease.
7.Subjects with pre-existing allergies such as titanium allergy or known allergy to any component part of the investigational device.
8.Subjects with skin anomalies such as skin infections, skin disorders, hypersensitive skin at the potential target implantation site.
9. Subjects who have a topical or active subcutaneous infection associated with the implantation site.
10. Subjects who have local tissue factors that will prevent proper device stabilisation or access.
11.Subjects with uncontrolled diabetes mellitus defined as HbA1c of = 10% or its equivalent, for a duration of at least 1 year.
12.Subjects with uncontrolled coagulation disorders.
13. Subjects determined to be an unsuitable candidate for self- cannulation.

AVF Related Exclusion
14. Subjects who underwent a surgical revision on the target AVFinvolving placement of a prosthetic graft.
15. Subjects with history of more than two intervention per year on the target AV-fistula.
16. Subjects with recent intervention on the target AV-fistula < 3 months.
17. Subjects are unable to complete at least one dialysis session at the chosen implant site cannulation segment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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