End-stage renal disease
Conditions
Interventions
LifeSpan ePTFE Vascular Graft group:Arteriovenous anastomosis by LifeSpan ePTFE Vascular Graft
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) requiring maintenance hemodialysis (MHD) and intending to undergo graft arteriovenous fistula (AVG); 2, age 18-75 years old; 3. Subjects who are able to place artificial vascular access in the upper limb; 4. Preoperative hemoglobin =80g/L and platelet count =80*109/L; 5. No significant abnormal liver function before operation: defined as serum bilirubin =1.5mg/dL; GGT, AST, ALT and ALP= 2 times the upper limit of normal reference value (URL) and International Standardized ratio (INR) =1.5; 6. Subjects who can understand the purpose of the experiment, voluntarily participate in and sign informed consent, and are willing to accept vascular implantation and clinical follow-up; 7. Life expectancy =1 year.
Exclusion criteria
Exclusion criteria: 1. Serious heart disease: including New York Heart Function Scale (NYHA) III-IV severe heart failure, or a history of myocardial infarction, unstable angina, or rapid ventricular arrhythmia requiring continuous treatment within 6 months; 2. Uncontrolled or poorly controlled diabetes (HBA1c >8% after admission, or poor blood sugar control within the past 3 months); 3. Serious peripheral vascular disease that the physician believes increases the risk of ischemia in the subject's operative limb; 4. Patients with known central venous lesions on the surgical side, or with a history of symptoms, signs, catheter placement, etc., who are highly suspected of central venous lesions and have not been clearly ruled out by imaging examination; 5. History of stroke within 6 months; 6. Those who plan to undergo kidney transplantation within 1 year; 7. Hypoproteinemia (blood albumin 10mg); 15. History of heparin-induced thrombocytopenia (HIT); 16. Previously implanted grafts that interfere with reoperation; 17. Have a history of bacterial infection within one month or currently have a local or systemic bacterial infection at the surgical site (white blood cell count >15*109/L); 18. The anastomosis is located in the part that is difficult to be monitored by ultrasound; 19. There are mental factors should not accept artificial blood vessel implantation surgery; 20. The subject is participating in another drug or medical device clinical trial has not yet been enrolled; 21. Any other circumstances which, in the opinion of the investigator, may prevent an adequate assessment of the safety and efficacy of the device under test; 22. Subjects with a known allergy to products of sheep origin.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Immediate surgical success rate;Instrument performance evaluation;First puncture time of transplanted blood vessels;Primary patency rate;Auxiliary primary patency rate;Incidence of transplanted blood vessel stenosis; | — |
Primary
| Measure | Time frame |
|---|---|
| Cumulative patency rate at 12 months after surgery; | — |
Countries
China
Contacts
Public ContactYu Zhao
The First Affliated Hospital of Chongqing Medical University
Outcome results
None listed