Paclitaxel-Coated Balloon for the Treatment of AVF

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.

Official Title
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Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)

Conditions
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Arteriovenous Fistula

Intervention / Treatment
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* Device: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age during 18-85 years old Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions Venous stenosis of the AV fistula target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow the length of target lesion ≤100mm Patient able to give informed consent residual stenosis ≤30% after predilation Exclusion Criteria: Women who are breastfeeding, pregnant or are intending to become pregnant AVF located at lower limbs Two or more than two stenosis at the target vessel. Obstruction of central venous return ISR AVF with acute thrombosis requiring lysis or thrombectomy in 30 days Vascular access has surgery in 30 days or intending to undergo a surgery Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc. Patients undergoing immunotherapy or suspected / confirmed vasculitis Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura Vascular access infection or systemic active infection Patients's life expectancy is less than 12 months Renal transplantation has been planned or converted to peritoneal dialysis Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB Treatment Group<br>Subjects treated with DCB | Device: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon<br>* After predilation, using drug-coated balloon catheter to cover the whole treated segment<br>* Other names: Zylox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency of target lesion in 6 months | Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Successful delivery to the target lesion, deployment, and retrieval at index procedure | Time of procedure | 
| Clinical Success | The resumption of dialysis for at least one session after the index procedure | From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure. | 
| Procedural Success | Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCB