Peripheral Arterial Disease
Conditions
Brief summary
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Detailed description
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.
Interventions
PROCEDURERapamycin drug balloon angioplasty
Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
PROCEDUREPaclitaxel drug balloon angioplasty
Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
Sponsors
Shanghai Bomaian Medical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month target lesion primary patency rate | 6months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success rate | The day of operation. | The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure. |
| Surgical success rate | 7Days | 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. |
| Clinical success rate | 1year | 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. |
Contacts
Primary Contactqizhuang Jin
Outcome results
None listed