Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

University College London (UCL)

Status

Not yet enrolling

Conditions

Renal Insufficiency

Treatments

Device: POSS-PCU vascular graft

Study type

Interventional

Funder types

Other

Identifiers

NCT02301312

14/0276

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).