Stenosis of dialysis access in hemodialysis patients with autogenous arteriovenous fistula
Conditions
Interventions
Experimental group:Drug high-pressure shunt balloon dilatation catheter
Control group:Paclitaxel releases a high-pressure shunt balloon to dilate the catheter
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old and =75 years old, male or female; 2. Patients with hemodialysis access dysfunction due to stenotic lesions as indicated by angiography or ultrasound or clinical diagnosis; 3. Indications for endovascular treatment were defined as a target lesion stenosis that was hemokinetically relevant and greater than 50% in combination with one or more of the following clinical and physiological abnormalities (defined according to the NKF-K/DOQI guidelines) : 1) previous vascular access thrombosis; 2) Significantly increased venous pressure during dialysis; 3) significant circulatory abnormalities; 4) abnormal physical examination; 5) unexplained dialysis dose decline; 6) decreased vascular access blood flow; 4. Single or tandem lesions with target lesion length =60mm; 5. The target lesion was located in the fistula vein, which was anastomosed with autogenous arteriovenous fistula, and the rest were distal subclavian vein (excluding central vein, arteriovenous fistula anastomosis and cephalic venous arch); 6. If there are other non-target lesions, the non-target lesions (such as in the subclavian vein, etc.) must be successfully treated with ordinary balloon before treating the target lesions; 7. Target lesion reference vessel diameter =4.0 mm, =8.0 mm (assessed by angiography or ultrasound); 8. AVF is mature and has successfully completed at least one hemodialysis session; 9. The subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to accept the follow-up specified by the trial at a specific time point.
Exclusion criteria
Exclusion criteria: 1. Clinical judgment of central venous stenosis; 2. Pregnant or planning to become pregnant or lactating women; 3. Patients with recent (within 30 days) major surgery (e.g., thoracotomy, cranial surgery) or planned surgery; 4. Recent (within 30 days) vascular access for thrombolysis and/or thrombectomy; 5. Immature AVF (due to insufficient lumen diameter, no guarantee of puncture success, insufficient shunt flow, no Dialysis or unsuccessful use); 6. AVG patients; 7. AVF stents were implanted; 8. AVF lesions had been treated with DCB before; 9. Known allergy or intolerance to paclitaxel or contrast media or antiplatelet drugs; 10. Life expectancy of patients less than 1 year; 11. Patients undergoing immunotherapy or with suspected/confirmed vasculitis; 12. Patients with previous history of coagulopathy or thrombocytopenic purpura; 13. Vascular access infection or active systemic infection; Protocol number: EFDon-01 Version number: V1.0 14. Kidney transplantation or conversion to peritoneal dialysis is planned; 15. Patients enrolled in clinical trials of drugs or other medical devices; 16. The investigator judged that the patient had poor compliance, was unable to complete the study as required, or had other discomfort Medical information of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate of target lesion (TLPP) at 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Clinical SUCCESS rate;success rate of operation;Incidence of target lesion restenosis;Incidence of clinically driven target lesion reintervention (6 months, 12 months);Primary patency rate of target lesion (12 months, 24 months);Incidence of death within 1, 3, 6, 12 and 24 months after operation.;Incidence of stroke at 1, 3, 6, 12 and 24 months after surgery.; | — |
Countries
China
Contacts
Public ContactShi Yaxue
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed