AcoArt III / Arterio-venous Fistula in China

Study Overview
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Brief Summary
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This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

Detailed Description
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For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. 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 and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.

Official Title
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Drug-eluting Balloon for Arteriovenous Fistula in China

Conditions
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Arteriovenous Fistula Stenosis

Intervention / Treatment
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* Device: drug-coated balloon catheter （Orchid, Acotec）
* Device: plain balloon catheter (Admiral, medtronic)


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB group<br>this group treated with drug coated balloon catheter, Orchid | Device: drug-coated balloon catheter （Orchid, Acotec）<br>* After predilation, using drug-coated balloon catheter to cover the whole treated segment<br>|
| Experimental: PTA group<br>this group treated with plain balloon catheter, Admiral Xtreme | Device: plain balloon catheter (Admiral, medtronic)<br>* After predilation, using plain balloon catheter to cover the whole treated segment<br>|

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)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency of target lesion in 12 months | Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated | 12 months | 
| number of reinterventions | number of reinterventions in 12 months | 12 months | 
| 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 period | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon