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.

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Access Failure
• Intervention / Treatment: Device: Paclitaxel-eluting graft

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DaeJoong Kim; Phone Number: 82234103441; Email: daejoongsmc.kim@samsung.com
• Study Contact Backup: Name: Dae Joong Kim

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Dae Joon g Kim
    • Principal Investigator: Dae Joong Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paclitaxel-eluting graft; Single-arm	Device: Paclitaxel-eluting graft; Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary patency	Percentage of no permanent failure of AVG	Up to 2 years after implantation of AVG

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Dae Joong Kim, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: hemodialysis; vascular access; arteriovenous graft; paclitaxel-eluting graft
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: SMC 2018-03-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No