This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.
1. Evaluation of safety Primary outcome: all adverse events occurring in the subject 2. Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis
Samsung Medical Center
Seoul, South Korea
RECRUITINGAdverse events
All adverse events occurring in the subject
Time frame: Up to 2 years after implantation of AVG
Primary patency
Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis
Time frame: at 6 months after implantation of AVG
Secondary patency
Percentage of no permanent failure of AVG
Time frame: Up to 2 years after implantation of AVG
Dae Joong Kim
CONTACT
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