Arteriovenous Graft
Conditions
Keywords
Arteriovenous Graft, Hemodialylsis, End Stage Kidney Disease(ESKD)
Brief summary
The study is planned to be conducted at multiple centers, with an intended enrollment of 326 subjects. Protocol-eligible subjects will be randomized in a 1:1 ratio to either the investigational group or the control group. The investigational group will receive a Biological Vascular Graft(LineMatrix®) manufactured by Humatrix Medical Technology (Suzhou) Co., LTD, while the control group will receive an arteriovenous graft (GORE-INTERING®) manufactured by W.L. Gore & Associates, Inc. The primary endpoints are the Primary patency rate at 6 months postoperatively and the Cumulative Patency Rate at 12 Months postoperatively. Subjects will undergo follow-up during the screening period, at the time of AVG procedure, and at 1 month, 3 months, 6 months, and 12 months post-operatively. Safety and efficacy parameters will be observed and recorded during and after the surgery to evaluate the safety and effectiveness of the LineMatrix® Biological Vascular Graft for the creation of arteriovenous graft in patients with end-stage renal disease (ESRD).
Interventions
LineMatrix® Biological Vascular Graft
DEVICEGORE-INTERING®
GORE-INTERING®
Sponsors
Longhua Hospital
Humatrix Medical Technology (Suzhou) Co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (1) Age ≥18 years and ≤80 years, male or female; * (2) Diagnosed with end-stage renal disease (ESRD) requiring maintenance hemodialysis; * (3) Requiring establishment of a long-term hemodialysis vascular access but unable to have a autologous arteriovenous fistula (AVF) created; * (4) Assessed by the investigator as suitable for implantation of an arteriovenous graft (AVG) in the upper extremity; * (5) Able to understand the purpose of the study, voluntarily participating and providing signed informed consent(ICF), and willing to comply with all scheduled follow-up assessments.
Exclusion criteria
* (1) Known or suspected history of allergy to heparin, alcohol, or bovine-derived products; * (2) Planned to undergo renal transplantation or transition to peritoneal dialysis within 1 year; * (3) Hemoglobin concentration \<60 g/L, or platelet count \<60 × 10⁹/L; * (4) Left ventricular ejection fraction (LVEF) \<30%; * (5) Severe cardiac disease, including New York Heart Association (NYHA) Class III-IV severe heart failure, or history of myocardial infarction, unstable angina, or sustained ventricular tachyarrhythmia requiring continuous treatment within 6 months prior to enrollment; * (6) History of stroke within 1 month prior to enrollment; * (7) Uncontrolled or poorly controlled diabetes mellitus (preoperative glycated hemoglobin \>10%); * (8) Immunodeficiency disorders, or current treatment with corticosteroids (prednisone-equivalent dose ≥10 mg) or immunosuppressive agents (e.g., sirolimus, mycophenolate mofetil, cyclosporine, cyclophosphamide, tacrolimus); * (9) Malignancy or other severe systemic disease with a life expectancy of \<12 months; * (10) Heparin-induced thrombocytopenia type II (HIT-2) or other contraindications to heparin use; * (11) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 × upper limit of normal (ULN); * (12) Coagulation disorders (activated partial thromboplastin time \[APTT\] or prothrombin time \[PT\] \>1.5 × ULN); * (13) Systemic or surgical site infection (white blood cell \[WBC\] count \>15 × 10⁹/L); * (14) Baseline hypotension, or frequent hypotensive episodes within the past month (frequency ≥5 episodes/month, with hypotension defined as systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg); * (15) Hypercoagulable state, or history of ≥2 episodes of deep vein thrombosis or peripheral vascular thrombosis not related to dialysis access; * (16) Known ipsilateral central venous stenosis, or clinical symptoms/signs suggestive of central venous stenosis confirmed by imaging; * (17) Severe mental disorders that preclude cooperation with the study protocol; * (18) Pregnant or lactating women, or women of childbearing potential who plan to conceive during the trial and are unwilling to use effective contraception; * (19) Currently enrolled in another drug or medical device clinical trial and not yet completed the study; * (20) Any other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 6 months postoperatively | 6 months | Primary Patency Rate is defined as the proportion of subjects who have not experienced any of the following events from the date of vascular access creation through 6 months post-operatively: thrombosis, or any intervention performed to promote, maintain, or re-establish patency (e.g., angioplasty). |
| Cumulative Patency Rate at 12 Months Postoperatively | 12 months | Cumulative Patency Rate is defined as the proportion of subjects whose vascular access has not been abandoned from the date of vascular access creation through 12 months post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate at 3,12 months postoperatively | 3,12 months | Primary Patency Rate is defined as the proportion of subjects who have not experienced any of the following events from the date of vascular access creation through 3,12 months post-operatively: thrombosis, or any intervention performed to promote, maintain, or re-establish patency (e.g., angioplasty). |
| Cumulative Patency Rate at 3,6 Months Postoperatively | 3,6 months | Cumulative Patency Rate is defined as the proportion of subjects whose vascular access has not been abandoned from the date of vascular access creation through 3, 6 months post-operatively. |
| Surgical success rate | 30 days | Surgical success rate is defined as the successful completion of the arteriovenous graft (AVG) surgery using the investigational device, without any device-related serious adverse events occurring during the perioperative period. |
| Time to First Cannulation | 12 months | Time to First Cannulation is defined as the interval from the AVG procedure to the first hemodialysis session performed using the arteriovenous graft. |
| Device Performance Evaluation | 12 months | I.Suturability Excellent: Needle passes through vessel with light touch and no deformation after arterial suturing; Good: Needle passes through vessel with light force and shows deformation after arterial suturing but can continue to be used; Poor: Needle passes through vessel with force and shows severe deformation after arterial suturing and cannot continue to be used. II.Anastomotic bleeding No: No visible blood leakage at anastomosis; Yes: Visible blood leakage at anastomosis. III.Post-cannulation hemostasis Excellent: After removal of the puncture needle, apply manual compression to achieve hemostasis; time to hemostasis is \<10 min. Good: After removal of the puncture needle, apply manual compression to achieve hemostasis; time to hemostasis is 10-15 min. Poor: After removal of the puncture needle, apply manual compression to achieve hemostasis; time to hemostasis is \>15 min, or additional hemostatic measures are required. |
Countries
China
Contacts
CONTACTXuefeng Qiu
PRINCIPAL_INVESTIGATORYaxue Shi
Longhua Hospital
PRINCIPAL_INVESTIGATORHua Li
Sir Run Run Shaw Hospital
Outcome results
None listed