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.

Not Applicable

• Conditions: Hemodialysis Access Failure
• Interventions: Device: Paclitaxel-eluting graft

• Registration Number: NCT04285073
• Lead Sponsor: Samsung Medical Center

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 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

Study Timeline

• Study Start: 2018-11-13
• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Last Update Submitted: 2020-02-24
• Study First Posted: 2020-02-26
• Last Update Posted: 2020-02-26
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel-eluting graft	Paclitaxel-eluting graft	Single-arm

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 2 years after implantation of AVG	All adverse events occurring in the subject
Primary patency	at 6 months after implantation of AVG	Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis

Secondary Outcome Measures

Name	Time	Method
Secondary patency	Up to 2 years after implantation of AVG	Percentage of no permanent failure of AVG

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of