Hemodialysis access related vascular stenosis or occlusion
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years old 50%; (2) The patient had clinical symptoms consistent with the stenosis, such as increased dialysis venous pressure, decreased natural blood flow of internal fistula (AVF < 500ml/min or AVG < 600mL/min), decreased pump controlled flow during dialysis, tumor-like expansion of internal fistula with positive arm elevation test, and limb swelling; 5. The stenosis degree of other vessels other than the target lesion is <=50% and does not need to be treated; 6. Target lesions are primary or restenosis lesions, the reference vessel diameter is between 6.0 and 14.0mm, and the total length is no more than 150mm(a single stent can fully cover the lesion); 7. Voluntarily participate in the study, understand all risks and benefits described in the informed consent document, and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who received major surgical treatment within 30 days before admission (e.g., thoracotomy, craniotomy, etc.); 2. Patients known to be allergic to contrast agent, heparin, lidocaine and other drugs or polytetrafluoroethylene (ePTFE), Nitinol substance; 3. Patients with severe liver dysfunction (ALT> 3 times the upper limit of normal); 4. Patients who have received or are planning kidney transplantation or are planning to be transferred to peritoneal dialysis; 5. patients with known bleeding that cannot be corrected or severe coagulopathy; 6. Patients with known systemic lupus erythematosus, vascular access infection, or systemic active infection; 7. Patients with long-term hypotension or heart failure during dialysis; 8. The stent to be placed may enter or affect the puncture segment, resulting in patients with high risk of stent puncture; 9. Patients with high natural blood flow of internal fistula (AVF>=2000ml/min or AVG>=2000ml/min); 10. Patients whose target lesions cannot fully expand and thus the delivery system cannot pass; 11. Patients with severe calcification of target lesions; 12. Patients with target lesions who had been implanted with stents; 13. Patients with target lesions located at AVF anastomosis or AVG arterial end anastomosis; 14. At the time of admission, they were patients with thrombosis occlusion secondary to stenosis; 15. Patients with other diseases that may make the trial difficult or significantly shorten life expectancy (<1 year); 16. Pregnant and lactating women; 17. Patients who are participating in clinical trials of other drugs or medical devices; 18. Patients considered unsuitable for inclusion for other reasons by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The stent patency rate at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Success rate of operation;Clinical success rate;TLPP (Target Lesion Primary Patency) of 6 months after surgery;Secondary patency rate of target lesion 3 months, 6 months, 12 months after surgery;Primary patency rate of vascular access at 3 months, 6 months and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactYu Zhao
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed