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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapamycin coated balloon dilation catheter for arteriovenous fistula | Experimental | Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion |
|
| Paclitaxel release high-pressure shunt balloon dilation catheter | Sham Comparator | Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin drug balloon angioplasty | Procedure | Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure. | The day of operation. |
| Surgical success rate |
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Inclusion Criteria:
exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qizhuang Jin | Contact | 010-83572211 | jinqizhuang@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Paclitaxel drug balloon angioplasty | Procedure | Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula. |
|
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. |
| 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. | 1year |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |