Hemodialysis
Conditions
Interventions
Experimental group:The experimental group used heparin-coated artificial blood vessels to establish hemodialysis access.
Control group:The control group used a similar product in the city of the study - GORE PROPATEN Vaseular Graft (registration certificate number: Guoxin Injection 20153133918).
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Non-wearable queues: (1)Age 18 to 75 years old (including 18 years old and 75 years old);(2)Patients with end-stage renal disease who need to receive long-term dialysis treatment;(3)Patients who need to establish long-term hemodialysis access but cannot establish an autologous arteriovenous fistula;(4)Patients who are currently undergoing hemodialysis or are ready to start hemodialysis within 30 days of implantation of the investigational device;(5)Patients who are able to place artificial vascular dialysis access in the upper limbs;(6)Patients who are expected to be able to maintain hemodialysis for 12 months or more;(7)Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to accept vascular placement and clinical follow-up. 2.Wearable queues :In addition to meeting the inclusion criteria for the non-wearable cohort, the following criteria must be met: Patients with central venous disease who require the use of a ready-to-wear prosthetic vessel.
Exclusion criteria
Exclusion criteria: 1.Patients with ipsilateral central venous stenosis and subclavian artery stenosis; 2.Patients with systemic infection or suspected systemic infection or local infection in the surgical area; 3.Patients who have had type II heparin-induced thrombocytopenia (HIT) in the past or who are known to be allergic to heparin; 4.There are mental factors that are not suitable for artificial vascular implantation; 5.Left ventricular ejection fraction less than 30%; 6.Patients with serious lesions of other organs such as heart and cerebrovascular within 1 month before operation (such as myocardial infarction, unstable angina pectoris, tachyventricular arrhythmia, stroke, etc.); 7.Systemic diseases: systemic lupus erythematosus, AIDS, vasculitis; 8.Patients who need or plan to undergo other artificial vascular surgery within 30 days of transartificial angiostomy; 9.Patients who have undergone ipsilateral breast tumor surgery (including lymph node dissection); 10.Patients who are receiving immunosuppressant drugs (such as rapamycin, mycophenolate or mycophenolic acid mofetil, prednisone >10mg, cyclosporine, tacrolimus or cyclophosphamide); 11.Patients with implanted pacemakers; 12.Participated in another clinical trial of drugs or medical devices within 3 months before surgery; 13.Pregnant or lactating females; 14.Patients who are considered by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative patency rate(12 months postoperatively); | — |
Secondary
| Measure | Time frame |
|---|---|
| Device performance evaluation;Primary patency;Cumulative patency rate;Surgical success rate; | — |
Countries
China
Contacts
Public ContactWeiguo Fu
Zhongshan Hospital, Fudan University
Outcome results
None listed