End-stage renal disease
Conditions
Interventions
Bioengineered Vascular Grafts Group:Establishment of Hemodialysis Access Using Bioengineered Vascular Grafts
Sponsors
Sir Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Adults aged 18 to 75 years, inclusive, of any sex. (2) Patients diagnosed with end-stage renal disease and requiring maintenance hemodialysis. (3) Patients requiring long-term hemodialysis access who are not longer, candidates for creation of an autologous arteriovenous fistula and therefore need placement of an arteriovenous graft; (4) Patients who are evaluated by investigators to be suitable for placement of a vascular graft in the upper limb. (5) Patients who are able to understand the purpose of the study, voluntarily participate, and provide written informed consent.
Exclusion criteria
Exclusion criteria: (1) Known or suspected allergy to heparin or bovine-derived products. (2) Planned kidney transplantation within the next 6 months. (3) Left ventricular ejection fraction 10%, or hospitalization due to poor glycemic control within the past 3 months. (8) Presence of immunodeficiency diseases or currently receiving immunosuppressive treatment. (9) Active malignancy or other severe systemic disease with life expectancy 2× the upper limit of normal. (12) Coagulation abnormalities, defined as APTT or PT > 1.5× the upper limit of normal. (13) Systemic or surgical site infection, with WBC > 15 × 10?/L. (14) Hypotension (systolic BP < 90 mmHg or diastolic BP < 60 mmHg) likely to compromise dialysis blood flow. (15) Known central venous stenosis or radiologically confirmed stenosis with related symptoms/signs. (16) Severe psychiatric disorders that interfere with study compliance. (17) Pregnant or breastfeeding women, or women planning pregnancy during the study period. (18) Participation in another drug or medical device clinical trial within the past month or currently enrolled. (19) Deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency Rate at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Patency Rate at 6 months;Cumulative Patency Rate at 3, 6 months;Primary-assisted Patency Rate at 3, 6 months;Surgical Success Rate;First Puncture Time;Performance Evaluation of Bioengineered Vascular Grafts;Adverse Event;Medical Device Defects; | — |
Countries
China
Contacts
Public ContactHua Li
Sir Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed