AcoArt III / Arterio-venous Fistula in China

Drug-eluting Balloon for Arteriovenous Fistula in China

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

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.

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