End-stage renal disease
Conditions
Interventions
Trial group:LineMatrix Naimaitong? biologic artificial blood vessel (model specifications: LM-610, LM-615, LM-620, LM-630, LM-640)
Control group:GORE INTERING? artificial blood vessel (model specifications: IRS06040L, natural state inner diameter 6mm, effective length 40cm)
Sponsors
Sir Run Shaw Hospital, Zhejiang University School of Medicine; Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 80 years, inclusive; 2. Patients with end-stage renal disease and requiring maintenance hemodialysis; 3. Patients who need to establish long-term hemodialysis access but cannot establish an autologous arteriovenous fistula; 4. Patients who are evaluated by investigative staff to be suitable for placement of a vascular graft in arms; 5. Patients who are able to communicate effectively with investigative staff, competent and willing to give written informed consent, and are able to comply with entire study procedures including all scheduled follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to heparin, alcohol, and bovine-derived products; 2. Anticipated renal transplant or peritoneal dialysis within one year; 3. Hemoglobin 10%); 8. Patients with autoimmune diseases or currently receiving glucocorticoid treatment (converted to prednisone dose >= 10 mg), or receiving immunosuppressive treatment (such as rapamycin, mycophenolate, cyclosporine, cyclophosphamide, tacrolimus); 9. Active malignancy or other severe systemic disease with life expectancy 2× the upper limit of normal; 12. Coagulation abnormalities (APTT or PT > 1.5× the upper limit of normal); 13. Systemic or surgical site infection (WBC > 15 × 10^9/L); 14. Baseline hypotension or frequent hypotension within 1 month (occurrence frequency >= 5 times/month, hypotension is defined as systolic BP < 90 mmHg or diastolic BP < 60 mmHg); 15. Documented hyper-coagulable state or a history of twice or more episodes of deep vein thrombosis or peripheral vascular thrombosis except for thromboembolism related to dialysis access; 16. Known central venous stenosis on the ipsilateral side of planned implantation or radiologically confirmed stenosis with related symptoms/signs; 17. Severe psychiatric disorders that interfere with study compliance; 18. Pregnant or breastfeeding female, intending to become pregnant, or unable to use a highly effective method of birth control during the study period; 19. Participation in another drug or medical device clinical trial has not yet been completed before enrollment; 20. There are other factors deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate at 6 months after implantation of vascular graft;Cumulative patency rate at 12 months after implantation of vascular graft; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency rate at 3, 12 months after implantation of vascular graft;Cumulative patency rate at 3, 6 months after implantation of vascular graft;Surgical success rate;First puncture time;Performance evaluation of bioengineered vascular graft; | — |
Countries
China
Contacts
Public ContactLi Hua, Shi Yaxue
Sir Run Shaw Hospital, Zhejiang University School of Medicine; Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed