end-stage renal disease
Conditions
Interventions
Test group:Establishing a hemodialysis access using the Maishulin artificial blood vessel
Control group:Establishing a hemodialysis access using the LifeSpan ePTFE Vascular Graft artificial blood vessel
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, gender not restricted; 2. Suffering from end-stage renal disease (ESRD) and requiring maintenance hemodialysis (MHD) treatment, and planning to undergo arteriovenous fistula formation (AVG) for transplantation; 3. Capable of placing an artificial vascular access in the upper limb; 4. Expected lifespan >= 1 year; 5. Able to understand the purpose of the trial, voluntarily participate and sign the informed consent form, and willing to undergo vascular insertion and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Women who are breastfeeding, pregnant, or planning to conceive within the next 12 months; 2. Those with severe heart diseases: including NYHA Class III-IV severe heart failure, or a history of myocardial infarction, unstable angina pectoris, or rapid-type ventricular arrhythmia that requires continuous treatment within 6 months; 3. Those with uncontrolled or poorly controlled diabetes (glycated hemoglobin > 8% after admission, or hospitalization due to poor blood sugar control within the past 3 months); 4. Those with severe peripheral vascular diseases that the doctor considers increasing the risk of ischemia in the surgical side limb; 5. Those with known central venous lesions on the surgical side, or with symptoms, signs, or relevant history of related conditions (such as catheter insertion), and suspected central venous lesions that have not been excluded by imaging examination; 6. Those with a history of stroke within 6 months; 7. Those planning to undergo kidney transplantation within 1 year; 8. Those with left ventricular ejection fraction 1.5 mg/dL; GGT, AST, ALT, and ALP > 2 times the upper limit of normal (URL) and international normalized ratio (INR) > 1.5; 12. Those who frequently experience hypotension within 1 month (frequency >= 5 times/month, hypotension defined as systolic blood pressure 10 mg); 17. Those with a history of heparin-induced thrombocytopenia (HIT); 18. Those with a previously implanted graft that affects reoperation; 19. Those with a history of bacterial infection affecting surgical treatment within 1 month or currently have local infection at the surgical site or systemic bacterial infection (white blood cell count > 15 * 10?/L); 20. Those with mental factors making them unsuitable for artificial vascular implantation surgery; 21. Those who participated in other clinical trials within 3 months before screening; 22. Those considered by the researcher to be any other situation that may hinder the adequate assessment of the safety and effectiveness of the investigational device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The secondary patency rate of the artificial blood vessel 12 months after the operation;The primary patency rate of the artificial blood vessel 6 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| operation success rate;Secondary patency rate of artificial blood vessels (at 1, 3, and 6 months after surgery);Primary patency rate of artificial blood vessels (at 1, 3, and 12 months after surgery);Equipment performance evaluation;The first puncture time for the transplanted blood vessel; | — |
Countries
China
Contacts
Public ContactBo Hu
The First Affiliated Hospital of Jinan University
Outcome results
None listed