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.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hemodialysis Access Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 20 years and 80 years
- Gender
- Both males and females
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
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
Tracking Information
- NCT #
- NCT04285073
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dae Joong Kim Samsung Medical Center
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