Paclitaxel-Coated Balloon for the Treatment of AVF

Not Applicable

• Conditions: Arteriovenous Fistula
• Interventions: Device: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon

• Registration Number: NCT05088083
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Study Start: 2021-12
• Primary Completion: 2023-03
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCB Treatment Group	Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon	Subjects treated with DCB

Primary Outcome Measures

Name	Time	Method
primary patency of target lesion in 6 months	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

Secondary Outcome Measures

Name	Time	Method
Device Success	Time of procedure	Successful delivery to the target lesion, deployment, and retrieval at index procedure
Clinical Success	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.	The resumption of dialysis for at least one session after the index procedure
Procedural Success	2 weeks	Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).