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.

Samsung Medical Center

Status: Unknown

Conditions: Hemodialysis Access Failure

Treatments: Device: Paclitaxel-eluting graft

Study type: Interventional

Funder types: Other

Identifiers

NCT04285073

SMC 2018-03-017

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Paclitaxel-eluting graft

Experimental group

Description:

Single-arm

Treatment:

Device: Paclitaxel-eluting graft