Overview
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.
Description
- Evaluation of safety Primary outcome: all adverse events occurring in the subject
- Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency
Eligibility
Inclusion Criteria:
- Adult male or female between the ages of 20 and 80
- Patients currently undergoing or scheduled for hemodialysis due to end-stage kidney disease.
- Patients who decided to receive AVG procedure in forearm due to inability to perform autologous arteriovenous fistula (AVF)
- Patients with a high risk of stenosis (neointimal hyperplasia) or thrombosis when artificial blood vessels were implanted
Exclusion Criteria:
- Pregnant or lactating women
- Patients who are currently diagnosed with malignant tumors and are receiving chemotherapy or radiotherapy
- Patients with life expectancy less than 12 months
- Patients expected to receive a kidney transplant during the trial
- Patients with current or suspected infection
- Acute psychiatric problems require treatment
- Patients who have inserted a catheter into an artery or vein in their upper limb for AVG procedure within the last 30 days
- Patients with coagulation disorder, platelet count <50,000 / Ul
- Patients with a neutrophil count of less than 1,500 cells / mm3
- Patients judged to be unable to insert grafts by the operator