Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2025-04-30

Brief Summary

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This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and monitored at regular intervals for 18 months.

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Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POSS-PCU graft

POSS-PCU vascular graft will be used to create vascular access for dialysis.

Group Type EXPERIMENTAL

POSS-PCU vascular graft

Intervention Type DEVICE

New vascular access graft

Interventions

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POSS-PCU vascular graft

New vascular access graft

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects requiring vascular access for haemodialysis
* Subjects with no suitable vein.
* Subjects aged 18 - 80 years old
* Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
* Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment:

* Condom with spermicide.

AND 1 of the following:

* Oral contraceptive or hormonal therapy (e.g. hormone implants).
* Placement of an intra-uterine device.

Exclusion Criteria

* Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge)
* Subjects with left ventricle ejection fraction (LVEF) \<20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent.
* Pregnant or lactating
* Allergies to any constituents of the graft material
* Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No