Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Study Overview
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Brief Summary
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Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.

Detailed Description
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To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.

Official Title
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Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: Rapamycin drug balloon angioplasty
* Procedure: Paclitaxel drug balloon angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AVF has been established, with mature development and at least one successful completion of hemodialysis； AVF has significant hemodynamic abnormalities； exclusion criteria The target lesion has undergone intervention treatment within 30 days； An intravascular stent has been placed at any location along the vascular pathway；

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapamycin coated balloon dilation catheter for arteriovenous fistula<br>Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion | Procedure: Rapamycin drug balloon angioplasty<br>* Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.<br>Procedure: Paclitaxel drug balloon angioplasty<br>* Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.<br>|
| Sham Comparator: Paclitaxel release high-pressure shunt balloon dilation catheter<br>Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group | Procedure: Rapamycin drug balloon angioplasty<br>* Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.<br>Procedure: Paclitaxel drug balloon angioplasty<br>* Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month target lesion primary patency rate | Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery. | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success rate | The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure. | The day of operation. | 
| Surgical success rate | The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge. | 7Days | 
| Clinical success rate | After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before. | 1year |