stenosis of hemodialysis access
Conditions
Interventions
Group 1 :
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 <= age <= 80 years old; 2. The type of hemodialysis access where the stenosis is located is autogenous arteriovenous fistula (AVF) or graft arteriovenous fistula (AVG); 3. Stenosis of hemodialysis access, including primary stenosis and recurrent stenosis, that the investigator believes is suitable for treatment with paclitaxel-releasing high-pressure shunt balloon dilatation catheter. A diameter narrowing of the dialysis access that is hemodynamically related and greater than 50%, accompanied by one or more of the following clinical abnormalities: (1) Elevated dialysis venous pressure; (2) Reduced blood flow in vascular access; (3) Increased recirculation rate of vascular access; (4) Swelling of the extremity on the side of the vascular access; (5) Unexplained reduction in dialysis efficiency; 4. Patients who fully understand the nature and content of the research, agree to participate in this research and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Life expectancy < 2 years; 2. Hypersensitivity to any component of necessary drugs or research equipment, such as aspirin, clopidogrel, heparin, contrast medium, ticagrelor, bivalirudin, paclitaxel, ammonium shellac, etc.; 3. Female patients who are pregnant or cannot be ruled out for pregnancy, breastfeeding and planning pregnancy during the study period; 4. Patients who have been selected into this study or are participating in other clinical studies; 5. Patients who are using immunosuppressants or regularly use immunosuppressants; 6. Patients who have planned kidney transplantation; 7. The researchers think that it is not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| target lesion primary patency ; | — |
Secondary
| Measure | Time frame |
|---|---|
| device success;target lesion primary patency ;target shunt primary patency ;target lesion cumulative patency;target shunt cumulative patency ;all-cause death;thrombosis;pulmonary thromboembolism; | — |
Countries
China
Contacts
Public ContactQizhuang Jin
Peking University First Hospital
Outcome results
None listed