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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
New vascular access graft
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
Time frame: 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
Time frame: 30 days
Patency rate
Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.
Time frame: 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.
Time frame: 18 months
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