end-stage renal disease
Conditions
Sponsors
The First Affliated Hospital of chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with end-stage renal disease (ESRD) who require maintenance hemodialysis (MHD) treatment, are unable to establish autologous arteriovenous fistula (AVF), and prepare to undergo arteriovenous graft (AVG); 2. Age 18-75 years old; 3. Patients who are able to place biological artificial vascular access in the upper limb; 4. Preoperative hemoglobin >=80g/L and platelet count >=100*10^9/L; 5. No significant abnormal liver function before operation: defined as serum bilirubin =1 year.
Exclusion criteria
Exclusion criteria: 1. Severe heart disease: includes New York Rating of Heart Function (NYHA) III-IV severe heart failure, or a history of myocardial infarction, unstable angina, or rapid ventricular arrhythmia requiring ongoing treatment within 6 months; 2. Uncontrolled or poorly controlled diabetes (HBA1c >9% before surgery, or hospitalization due to poor blood sugar control within the past 6 months); 3. Severe peripheral vascular diseases of upper limbs; 4. Known or suspected central venous obstruction on the operative side; 5. History of stroke within 6 months; 6. Kidney transplant candidates; 7. Received vitamin K antagonists, factor Xa inhibitors, or direct thrombin inhibitors within 1 month; 8. Pregnant or lactating women, or women of childbearing age who had a family plan during the study period or were unable to take adequate contraceptive measures; 9. Patients with malignant tumor in the clinical active stage or receiving anti-tumor therapy; 10. Immunodeficiency diseases, including AIDS and HIV infection; 11. The blood is in a hypercoagulable state or has had 2 or more previous episodes of deep vein thrombosis or intravascular thrombosis other than thromboembolism associated with dialysis access; 12. Patients identified by the investigator as having a tendency to bleed; 13. Autoimmune disease with clinical activity, or being treated with immunosuppressive drugs (e.g., rapamycin, mycophonate, cyclosporine, cyclophosphamide, tacrolimus, or glucocorticoids converted to prednisone at a dose >10mg); 14. History of heparin-induced thrombocytopenia (HIT); 15. The previously implanted polytetrafluoroethylene (PTFE) graft remains in the operative limb, affecting the re-operation; 16. Surgical site local infection or systemic infection (preoperative white blood cell count >15x10^9/L); 17. In patients with upper arm graft anastomosis with axillary artery or axillary vein, the anastomosis is at a high position and cannot be monitored and compressed by ultrasound; 18. Biological artificial blood vessel implantation should not be accepted because of mental factors; 19. Patients with known allergy to products of sheep origin; 20. Treatment with any investigational drug or device within the 60 days prior to knowledge or the subject is participating in another clinical trial of a drug or medical device; 21. Any other circumstances which, in the opinion of the investigator, may prevent an adequate assessment of the safety and effectiveness of the device under test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of vascular graft-related complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;First puncture time of transplanted blood vessels;Primary patency rate;Secondary patency rate;Primary-assisted patency rate; | — |
Countries
China
Contacts
Public ContactYu Zhao
The First Affliated Hospital of chongqing Medical University
Outcome results
None listed