End-stage renal disease
Conditions
Interventions
Control group:This experiment adopts the central randomization method based on computer system. After the patients voluntarily signed the informed consent and met the screening criteria of the trial,
Experimental group:This experiment adopts the central randomization method based on computer system. When the patients signed the informed consent voluntarily and met the screening criteria, the resea
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
26 Years to 76 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-75 (including 18 and 75 years), male or female; (2) Patients with end-stage kidney disease who need to receive long-term dialysis treatment; (3) Patients who need to establish long-term hemodialysis access but not able to establish autologous arteriovenous fistula; (4) Patients who are currently receiving hemodialysis or are planning to begin the hemodialysis within 30 days; (5) Patients who are able to place artificial vascular access in the upper limb; (6) Patients who are expected to accept hemodialysis treatment for 12 months; (7) Patients who can understand the purpose of the trial, voluntarily participate in and sign informed consent, and are willing to accept graft implantation and clinical follow-up.
Exclusion criteria
Exclusion criteria: (1) The patient is now participating in another clinical trial of a drug or medical device; (2) Women who are pregnant or lactating (3) Left ventricular ejection fraction less than 30%; (4) Patients who are allergic to the material of the test instrument, or the investigator considers that the subject with poor compliance cannot complete the study as required; (5) Patients who have mental disorders that prevents them to accept the vascular implantation surgery; (6) Patients with serious lesions of heart, cerebrovascular and other organs within 1 month; (7) Patients with a life expectancy of less than 1 year; (8) Patients with ipsilateral central vein stenosis and unsuccessful treatment after imaging examination; (9) Patients with systemic infection or suspected systemic infection; (10) Patients who need or plan to undergo other vascular surgery within 30 days of undergoing artificial vasostomy; (11) Patients who are being treated with immunosuppressant drugs such as rapamycin, mycophenolate, or motechenolic acid, prednisone (> 10mg), cyclosporine, tacrolimus, or cyclophosphamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate at 6 months after implantation of vascular graft;Accumulatey patency rate at 12 months after implantation of vascular graft; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation success rate;Patency rate at 3 months after implantation of vascular graft;Operational valuation of products;Incidence of stenosis of intravascular fistula;Incidence of thrombosis;Incidence of hematoma/seroma;Incidence of forearm swelling;Incidence of pseudoaneurysm formation;Incidence of surgical site infection;Serious adverse event;Other vascular pathway events; | — |
Countries
China
Contacts
Public ContactYaxue Shi
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed