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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.

Hemodialysis Access Failure Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04285073
Study type Interventional
Source Samsung Medical Center
Contact DaeJoong Kim
Phone 82234103441
Email daejoongsmc.kim@samsung.com
Status Recruiting
Phase N/A
Start date November 13, 2018
Completion date December 31, 2023
View Details
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