NCT04285073

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemodialysis Access Failure

Interventions

Type	Name	Description
DEVICE	Paclitaxel-eluting graft	Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis

Timeline

• Start date: 2018-11-13
• Primary completion: 2021-12-31
• Completion: 2023-12-31
• First posted: 2020-02-26
• Last updated: 2020-02-26

Locations

1 site across 1 country: South Korea