Status:
UNKNOWN
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
Lead Sponsor:
Samsung Medical Center
Conditions:
Hemodialysis Access Failure
Eligibility:
All Genders
20-80 years
Phase:
NA
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 eP...
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 pate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04285073
Start Date
November 13 2018
End Date
December 31 2023
Last Update
February 26 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710