Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

Study Overview
=================
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.

Official Title
-----------------
A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access

Conditions
-----------------
Renal Insufficiency

Intervention / Treatment
-----------------
* Device: POSS-PCU vascular graft


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POSS-PCU graft<br>POSS-PCU vascular graft will be used to create vascular access for dialysis. | Device: POSS-PCU vascular graft<br>* New vascular access graft<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rate | 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 | 18 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rate | Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler. | 12 months | 
| Secondary patency rate | Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point. | 18 months |