AcoArt III / Arterio-venous Fistula in China

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.

• drug-coated balloon catheter （Orchid, Acotec） (Device): After predilation, using drug-coated balloon catheter to cover the whole treated segment
• plain balloon catheter (Admiral, medtronic) (Device): After predilation, using plain balloon catheter to cover the whole treated segment

Primary outcomes

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

Secondary outcomes

• primary patency of target lesion in 12 months [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
• number of reinterventions [12 months]: number of reinterventions in 12 months
• device success [during the procedure]: Successful delivery to the target lesion, deployment, and retrieval at index procedure
• clinical success [5 days]: The resumption of dialysis for at least one session after the index procedure
• Procedural Success [2 weeks]: residual stenosis≤30% and absence of SAE during perioperative period

Sex: All, ages: 18 Years to 85 Years

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

• Results publication: Zhao Y, Wang P, Wang Y, Zhang L, Zhao Y, Li H, He Q, Liu H, Luo J, Jia X, Yu Z, Guo W, Zhang L. Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2024 Mar 1;19(3):336-344. doi: 10.2215/CJN.0000000000000359. Epub 2023 Dec 18. PMID 38191561

• Wei Guo, Principal investigator, Chinese PLA General Hospital
• Lan Zhang, Principal investigator, RenJi Hospital