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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hemodialysis Access Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Paclitaxel-eluting graft

Single-arm

Group Type EXPERIMENTAL

Paclitaxel-eluting graft

Intervention Type DEVICE

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

Interventions

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Paclitaxel-eluting graft

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No