The disease of stenosis in arteriovenous fistula.
Conditions
Interventions
Drug-coated balloons group:None
Scoring balloons group:None
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The age range for the subjects is 18-75 years. 2.The subjects have a mature upper limb arteriovenous fistula and have undergone at least one blood dialysis session. 3.The target lesion must be located in the venous segment of the upper limb AVF. 4.Doppler ultrasound must confirm a target lesion’s stenosis degree of =50% and must be accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal AVF signs, and a significant decrease in dialysis blood flow (<200ml/min). 5.The guidewire and balloon pass smoothly through the lesion and complete the dilation. 6.The subjects, or their legal representative, must comprehend the trial’s purpose, willingly participate in the clinical trial, sign the informed consent form, and agree to undergo scheduled follow-ups according to the protocol.
Exclusion criteria
Exclusion criteria: The target lesions are located at the arterial segment and anastomosis of the arteriovenous fistula (AVF) in the lower limb. The subject has a history of stent implantation in the AVF. The patient has been diagnosed with symptomatic central venous occlusive disease, presenting with decreased AVF flow and accompanying edema in the limb, chest, and face on the same side. Additionally, a clear presence of central venous occlusive disease was confirmed by DSA. In this study, subjects with two or more target lesions in the AVF are included, with a distance of less than 3 cm between narrowings considered as one lesion. Furthermore, subjects with AVF complications such as acute thrombosis, recent thrombolysis treatment, previous thrombus removal, recent or planned surgical procedures within 30 days, infection, systemic active infection, planned kidney transplantation or conversion to peritoneal dialysis in the next 12 months, coagulation disorders, ongoing immunotherapy, suspected or diagnosed vasculitis, allergy, or contraindication to heparin and contrast agents, pregnancy, or breastfeeding women are excluded from the study due to the life expectancy being less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency rate of the target lesion at 12 month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reintervention rate for the target lesion at 12 months;primary patency rate of the target lesion at 3 month,6 month;Vascular access thrombosis rate at 12 months;primary patency rate of the target vascular access at 6 month,12 month;Total number of interventions for the target lesion at 6 and 12 months post-operation; | — |
Countries
China
Contacts
Public ContactYe hong
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed