End-Stage Renal Disease (ESRD) requiring hemodialysis
Conditions
Interventions
Trial Group:Implantation of novel small-to-medium caliber artificial blood vessels (model specifications: AMTN6060TL/AMTN4060TL)
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, either sex; 2. Patients with end-stage renal disease requiring long-term dialysis therapy; 3. Patients who require establishment of long-term hemodialysis access but in whom autologous arteriovenous fistula cannot be created; 4. Patients currently receiving hemodialysis or planning to initiate hemodialysis within 30 days after device implantation; 5. Patients in whom the vascular graft can be placed in the upper extremity; 6. Patients expected to maintain hemodialysis for 12 months; 7. Patients who are able to understand the purpose of the study, voluntarily participate and sign the informed consent form, and are willing to undergo vascular implantation and clinical follow-up;
Exclusion criteria
Exclusion criteria: 1. Patients currently participating in another drug or medical device clinical trial; 2. Pregnant or lactating women; 3. Left ventricular ejection fraction 10 mg], cyclosporine, tacrolimus, or cyclophosphamide);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency of synthetic graft at 6 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;Intraoperative product evaluation (ease of needle insertion, anastomosis difficulty, amount of bleeding at suture sites);Immediate postoperative cannulation dialysis success rate;Short-term cannulation dialysis success rate;Primary patency of synthetic graft at 3 and 12 months postoperatively;Secondary patency of synthetic graft at 12 months postoperatively; | — |
Countries
China
Contacts
Public ContactFeng Hai
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed