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Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable. However, the durability of PTA is limited. In order to reduce the risk of dysfunction recurrence after the intervention, there have been reports in recent years that drug-coated balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple factors have limited the efficacy of DCB. Previous studies on the related factors of hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore, the investigators applied a prospective, randomized, and controlled study method to preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9 inhibitor on improving the postoperative patency rate of AVF and the safety of the combined application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCSK9i group | Experimental | treatment group |
|
| control group | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pcsk9 inhibitor | Biological | The treatment group received postoperative use of 140 mg of Ribavirin, administered every two weeks, with 140 mg administered subcutaneously for a total of 48 weeks. There was no additional intervention with lipid-lowering drugs in the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Value of vessel diameter | ultrasonic measurement | 24 week, 48 week |
| Value of volume of blood flow | ultrasonic measurement | 24 week, 48 week |
| Value of peak systolic velocity ratio(PSVR) | ultrasonic measurement | 24 week, 48 week |
| Incidence of Re intervention of fistula | Event recording | 48 week |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrium | Ultrasonic measurement of changes in thickness of vascular intima , expressed in millimeters | 24 week, 48 week |
| RA | Arteriovenous fistula recirculation rate |
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Inclusion Criteria:
Agree to join this study and sign an informed consent form
Age ≥ 18 years old and ≤ 75 years old, regardless of gender
Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a dialysis frequency of three times a week
AVF venous stenosis: The local stenosis rate exceeds 50% of the normal diameter of nearby blood vessels and is accompanied by at least one of the following conditions:
Patients with primary Hypercholesterolemia [LDL-C ≥ 130 mg/dl (≥ 3.4 mmol/L), and/or non-HDL-C≥ 160 mg/dl (≥ 4.1 mmol/L)] or combine cardiovascular disease or assess patients with a high risk of cardiovascular disease
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuanyuan Xie | Recruiting | Shanghai | Pudong | 200127 | China |
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| 24 week, 48 week |
| BTM | Blood temperature monitoring, testing of specific modules of the hemodialysis machine. Expressed as a percentage. | 24 week, 48 week |
| Adequacy of dialysis | spKT/V | 24 week, 48 week |
| Blood routine | Concentration of hemoglobin, white blood cell count, platelet | 12 week, 24 week, 48 week |
| liver function | Concentration of GPT, GOT | 12 week, 24 week, 48 week |
| Concentration of blood sugar | 12 week, 24 week, 48 week |
| Concentration of CRP | 12 week, 24 week, 48 week |
| blood lipids | Concentration of cholesterol, triglyceride, LDL-c, HDL | 12 week, 24 week, 48 week |