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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
6-month target lesion primary patency rate
Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
Time frame: 6months
Device success rate
The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.
Time frame: The day of operation.
Surgical success rate
The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.
Time frame: 7Days
Clinical success rate
After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.
Time frame: 1year
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