A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV

Study Overview
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Brief Summary
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Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.

Detailed Description
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This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 10 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter

Official Title
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Evaluation of the Safety and Efficacy of the Peripheral Scoring Drug Balloon (Dissolve AV) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis A Prospective Multicenter Randomized Controlled Clinical Study

Conditions
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Fistulas Arteriovenous

Intervention / Treatment
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* Device: Dissolve AVF
* Device: Armada 35


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and ≤ 75 years, male or female. Arteriovenous fistula or Arteriovenous graft is matured and has undergone one or more hemodialysis sessions Venous stenosis of the AV fistula or AV graft target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1.Venous pressure increased significantly during dialysis,2.Abnomal phenomenon physical examination,3.Decrease in pumping blood flow. Target lesion consists of a single lesion or a multiple lesions with target lesion length ≤ 40 mm. Reference vessel diameter of target lesion ≥ 4.0 mm and ≤ 7.0 mm. If patient has non-target lesion, the stenosis ≥50% and don't need to be treated. Patient able to give informed consent 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: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dissolve AVF Group<br>This group treated with Peripheral scoring drug balloon.Dissolve AVF | Device: Dissolve AVF<br>* Subjects in the test group will be treated with peripheral scoring drug balloon.<br>* Other names: Using Peripheral scoring drug balloon catheter to cover the whole treated segment;|
| Active Comparator: PTA Group<br>This group treated with plain balloon catheter.Armada 35 | Device: Armada 35<br>* Subjects in the test group will be treated with plain balloon catheter.<br>* Other names: Using plain balloon catheter to cover the whole treated segment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency rate of the target lesion at 6 month post procedure [ Target Lesion Primary Patency ] | Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate>30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline) including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of target lesion in 12 months | Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate >30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline)including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow. | 12 Month | 
| Device success | Successful delivery to the target lesion, deployment, and retrieval at index procedure | during the procedure | 
| Clinical success | The resumption of dialysis for at least one session after the index procedure | 5 days | 
| Procedural Success | residual stenosis≤30% and absence of SAE during perioperative perio | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis scoring Fistulas