Hemodialysis Access Failure
Conditions
Keywords
hemodialysis, vascular access, arteriovenous graft, paclitaxel-eluting graft
Brief summary
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.
Detailed description
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
Interventions
DEVICEPaclitaxel-eluting graft
Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 2 years after implantation of AVG | All adverse events occurring in the subject |
| Primary patency | at 6 months after implantation of AVG | Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary patency | Up to 2 years after implantation of AVG | Percentage of no permanent failure of AVG |
Countries
South Korea
Contacts
Primary ContactDaeJoong Kim
Backup ContactDae Joong Kim
Outcome results
None listed