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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.

NCT04285073 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-26

No results posted yet for this study

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.

Conditions

  • Hemodialysis Access Failure

Interventions

DEVICE

Paclitaxel-eluting graft

Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Dae Joong Kim · Samsung Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285073 on ClinicalTrials.gov