Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients

Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.

To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.

Inclusion Criteria:

1. AVF has been established, with mature development and at least one successful completion of hemodialysis；
2. AVF has significant hemodynamic abnormalities；

exclusion criteria

1. The target lesion has undergone intervention treatment within 30 days；
2. An intravascular stent has been placed at any location along the vascular pathway；