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

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 11 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

Inclusion criteria

• Age 18-75 years (inclusive), male or female;
• Patients with mature AVF/AVG and at least one successful hemodialysis session;
• Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
• With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A & B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
• De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;
• All non-target lesions must have <50% stenosis without clinical indication for treatment.
• Patients who have signed the informed consent form.

Exclusion criteria

• Patients who are participating in another clinical trial of a drug product or medical device;
• Patients previously enrolled in this trial;
• Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
• Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
• Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);
• Calcified lesions that are not expected to be dilated with a balloon;
• AVF/AVG implanted with a stent;
• AVF/AVG lesions previously treated with DCB;
• Target lesions located at the venous anastomosis of AVF/AVG;
• Impaired central venous reflux ;
• Presence of a stenotic lesion in the artery that severely interferes with blood flow;
• Patients with known allergy or intolerance to paclitaxel or contrast agent;
• Patients with a life expectancy of less than 1 year;
• Patients with concomitant systemic lupus erythematosus (SLE), ANCA-associated small vessel vasculitis;
• Patients with a history of coagulopathy or thrombocytopenic purpura;
• Patients treated with or scheduled to be treated with renal transplant or who have switched to peritoneal dialysis;
• Vascular access infections or active systemic infections;
• Presence of other medical conditions considered ineligible for the study as assessed by the investigator.