Arteriovenous GraftNCT07773051
LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft
A study testing LineMatrix® Biological Vascular Graft and GORE-INTERING® in people with Arteriovenous Graft, run by Longhua Hospital at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arteriovenous Graft
- What is being tested?
- LineMatrix® Biological Vascular Graft and GORE-INTERING®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 12 sitesChina
- Study dates
- 25 Aug 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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;
Show all 20Show fewer
- (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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality
Yuzhu Wang, +8618701387950, wyz4417@126.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Ziming Wan, +8618696635322, wanziming-001@163.com
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hua Li, +8613588706757, lihua@srrsh.com
- Recruiting
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Hua Jiang, +8613868057536, zyjianghua@163.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yan Yan, +8613879190111, kiddoc@163.com
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Hong Ye, +8613082552804, yehong@njmu.edu.cn
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Yaxue Shi, +8613918331840, drshiyaxue@163.com
- Recruiting
South China Hospital of Shenzhen University
Shenzhen, Guangdong
Yangdong Liu, +8618996353520, liuyangdong06@163.com
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Lihong Zhang, +8618633888311, cpx1998@sina.com
- Recruiting
Tongji Hospital Affiliated to Tongji Medical Collage of Huazhong University of Science and Technology
Wuhan, Hubei
Gang Xu, +8613507181312, xugangtjh@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Shifeng Yang, +8618092024077, nickpet12@126.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Pei Wang, +8613523467291, wangpei146@hotmail.com
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft
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).
- Conditions
- Arteriovenous Graft
- Being tested
- LineMatrix® Biological Vascular Graft, GORE-INTERING®
- Keywords
- Arteriovenous Graft, Hemodialylsis, End Stage Kidney Disease(ESKD)
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LineMatrix® Biological Vascular GraftDevice
LineMatrix® Biological Vascular Graft
GORE-INTERING®Device
GORE-INTERING®
| Study group | Role | What they receive |
|---|---|---|
| LineMatrix® Biological vascular graft | Experimental | Not described Receives: Device: LineMatrix® Biological Vascular Graft |
| GORE-INTERING® | Active comparator | Not described Receives: Device: GORE-INTERING® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate at 6 months postoperatively
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).
Measured: 6 months
Cumulative Patency Rate at 12 Months Postoperatively
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.
Measured: 12 months
Secondary outcomes (5)
Primary patency rate at 3,12 months postoperatively
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).
Measured: 3,12 months
Cumulative Patency Rate at 3,6 Months Postoperatively
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.
Measured: 3,6 months
Surgical success rate
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.
Measured: 30 days
Time to First Cannulation
Time to First Cannulation is defined as the interval from the AVG procedure to the first hemodialysis session performed using the arteriovenous graft.
Measured: 12 months
Device Performance Evaluation
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start25 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longhua Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Humatrix Medical Technology (Suzhou) Co., LTD
- Responsible party
- Principal investigator, Yaxue Shi, Longhua Hospital
- Investigators
- Yaxue Shi, Principal investigator, Longhua HospitalHua Li, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773051
- Sponsor's protocol ID
- HMX-002-CTP-00
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for the Creation of Arteriovenous Graft
- ClinicalTrials.gov ID
- NCT07773051
- Acronym / sponsor ID
- HMX-002-CTP-00
- Conditions
- Arteriovenous Graft
- Keywords
- Arteriovenous Graft, Hemodialylsis, End Stage Kidney Disease(ESKD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Longhua HospitalUniversity, hospital or other
- Collaborators
- Humatrix Medical Technology (Suzhou) Co., LTD
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LineMatrix® Biological vascular graft | Experimental | Device: LineMatrix® Biological Vascular Graft |
| GORE-INTERING® | Active comparator | Device: GORE-INTERING® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (20 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LineMatrix® Biological Vascular GraftLineMatrix® Biological Vascular Graft | Device | LineMatrix® Biological vascular graft |
| GORE-INTERING®GORE-INTERING® | Device | GORE-INTERING® |
Primary outcome
Primary patency rate at 6 months postoperatively
Time frame: 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
Time frame: 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.
5 secondary outcomes
Primary patency rate at 3,12 months postoperatively
Time frame: 3,12 months
Cumulative Patency Rate at 3,6 Months Postoperatively
Time frame: 3,6 months
Surgical success rate
Time frame: 30 days
Time to First Cannulation
Time frame: 12 months
Device Performance Evaluation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Related trials for Arteriovenous Graft
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Recruiting
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
End Stage Renal Disease (ESRD), Kidney Failure
RecruitingObservational study
WRAP North America
Venous Stenosis, Venous Occlusion
Not yet recruiting
Multi-Site STARgraft (10401) Trial
End Stage Renal Disease (ESRD)
Active, not recruiting
The Arteriovenous Vascular (AV) ACCESS Trial
End-Stage Kidney Disease, Hemodialysis Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaxue Shi principal investigator
Longhua Hospital
Hua Li principal investigator
Sir Run Run Shaw Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LineMatrix® Biological Vascular Graft and GORE-INTERING® in people with Arteriovenous Graft, run by Longhua Hospital at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuefeng Qiu (+8613507192551, xuefeng_qiu@humatrix-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate at 6 months postoperatively (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.