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 Overview
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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.

Detailed Description
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Evaluation of safety Primary outcome: all adverse events occurring in the subject Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency

Official Title
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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.

Conditions
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Hemodialysis Access Failure

Intervention / Treatment
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* Device: Paclitaxel-eluting graft


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, vascular access, arteriovenous graft, paclitaxel-eluting graft