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 | Unknown

• 1 other identifier: SMC 2018-03-017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Access Failure

Keywords

hemodialysis; vascular access; arteriovenous graft; paclitaxel-eluting graft

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary patency

  Up to 2 years after implantation of AVG

Study Arms (1)

Paclitaxel-eluting graft

EXPERIMENTAL

Single-arm

Device: Paclitaxel-eluting graft

Interventions

Paclitaxel-eluting graft DEVICE

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

Paclitaxel-eluting graft

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Study Officials

• Dae Joong Kim

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DaeJoong Kim

CONTACT

82234103441; daejoongsmc.kim@samsung.com

Dae Joong Kim

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: November 13, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

KR (1)