This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
Age ≥ 18 and ≤ 80 years old;
The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow < 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;
Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
Calcified lesions that are not expected to be expandable with balloons;
Patients with thrombosis at the access stenosis site;