Stenosis of arteriovenous fistula in hemodialysis patients
Conditions
Interventions
Scoring balloon group:None
Cutting balloon group:None
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Hemodialysis patients aged >= 18 and = 50% (by ultrasound), and one of the following clinical indicators exists at the same time: ipsilateral limb edema, changes in pulse characteristics, abnormal thrill, abnormal murmurs, increased venous pressure, new puncture difficulties, aspiration of thrombi, inability to reach target dialysis blood flow, prolonged haemostasis time after needle removal for 3 consecutive times, unexplained decrease in dialysis dose Kt/V (>0.2 units), decrease in brachial artery blood flow (brachial artery blood flow < 500ml/min or decreased by 20% compared with the previous follow-up visit), etc. 5. The guide wire and balloon successfully passed the lesion and completed the expansion. 6. Patients or their legal representatives are able to understand the purpose of the trial, voluntarily participate in the clinical trial, sign an informed consent form, and are willing to undergo the follow-up established by the trial at a specific point in time.
Exclusion criteria
Exclusion criteria: 1. The target lesion is located in the feeding artery, arterial anastomosis, cephalic arch. 2. The target lesion is located in the lower limb AVF. 3. A stent has been implanted in any part of the AVF. 4. The patients were diagnosed with symptomatic central venous occlusive disease: decreased AVF flow, accompanied by ipsilateral limb, chest, or facial edema, and DSA showed central venous occlusive disease. 5. The patients had two or more target lesions in AVF at the same time (when the two lesions were < 3 cm apart, it was considered as one target lesion) 6. The patients had AVF with acute thrombosis or had received AVF thrombolytic therapy or AVF thrombectomy in the past 30 days. 7. The patients had undergone or planned to undergo a surgical procedure within 30 days. 8. The patients had AVF infection or combined with systemic active infection. 9. The patients are scheduled for kidney transplantation or conversion to peritoneal dialysis within the next 12 months. 10. The patients had conditions that caused clotting disorders, such as thrombocytopenic purpura. 11. The patients are undergoing immunotherapy or have suspected/confirmed vasculitis. 12. The patients are allergic or contraindicated to heparin or contrast media. 13. The patients were pregnant or lactating women. 14. Life expectancy of the patients were < 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Primary Patency, TLPP for 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Lesion Primary Patency, TLPP for 3 months;Target Lesion Primary Patency, TLPP for 12 months;Access Circuit Primary Patency, ACPP for 6 months;Access Circuit Primary Patency, ACPP for 12 months;The total number of target lesion interventions for 6 months ;The total number of target lesion interventions for 12 months ;Reintervention rate of target lesions for 12 months;The incidence of access circuit thrombosis for 12 months;Technical success rate;Clinical success rate; | — |
Countries
China
Contacts
Public ContactWang Pei
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed