Renal Insufficiency
Conditions
Brief summary
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.
Interventions
DEVICEPOSS-PCU vascular graft
New vascular access graft
Sponsors
University College, London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate | 18 months | The primary performance end point of the study is the patency rate of the POSS-PCU graft at the end of the 18 months as measured with US Doppler, which will be compared to the known patency rate for the PTFE graft |
| Safety endpoint of this study is defined as any Serious Adverse Event related to the implantation procedure or device implantation within 30 days of implantation procedure | 30 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate | 12 months | Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler. |
| Secondary patency rate | 18 months | Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point. |
Contacts
Primary ContactNimrita Verma
Backup ContactJanice Tsui, MD FRCS
Outcome results
None listed