Peripheral Arterial DiseaseNCT07733076
LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
A study testing LineMatrix® Biological Vascular Graft in people with Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital.
Trial summary
Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- LineMatrix® Biological Vascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2028
- 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.Adults aged ≥18 and ≤80 years, inclusive;
- 2.Patients evaluated by the investigative staff as requiring infra-renal arterial bypass or arterial replacement, including but not limited to: ischemia, infection, trauma, arterial rupture;
- 3.For ischemic limbs requiring infra-inguinal arterial bypass, Rutherford stage 3-6; Ankle-Brachial Index (ABI) ≤0.6; Preoperative imaging showing at least one below-knee artery vessel patent to the ankle with good runoff; No whole-segment healthy great saphenous vein available;
- 4.Patients who are able to communicate effectively with investigative staff, competent and willing to give written informed consent, and are able to comply with entire study procedures including all scheduled follow-up visits.
Who cannot join
- 1.Distal target artery diameter <2.5mm;
- 2.Known or suspected allergy to contrast media, anticoagulant/antiplatelet drugs, alcohol, or bovine-derived products;
- 3.Hemoglobin <60g/L, platelet count <60×10⁹/L;
- 4.Left ventricular ejection fraction <30%;
- 5.Severe cardiac disease: including New York Heart Association (NYHA) Scale III-IV severe heart failure, or a history of myocardial infarction, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina within 3 months;
- 6.Stroke within 3 months prior to study entry;
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- 7.Uncontrolled or poorly controlled diabetes (preoperative glycated hemoglobin >10%);
- 8.Active inflammatory vascular disease;
- 9.Patients with autoimmune diseases or currently receiving immunosuppressive drug therapy;
- 10.Active malignancy or other severe systemic disease with life expectancy less than 12 months;
- 11.History of heparin-induced thrombocytopenia type II (HIT-II) or other contraindications to heparin use;
- 12.AST or ALT >2× the upper limit of normal;
- 13.Coagulation abnormalities (APTT or PT >1.5× upper limit of normal);
- 14.Severe psychiatric disorders that interfere with study compliance;
- 15.Pregnant or breastfeeding female, intending to become pregnancy, or could not use a highly effective method of birth control during the study period;
- 16.Patients in another drug or medical device clinical trials has not yet been enrolled before enrollment;
- 17.There are other factors that deemed unsuitable for study participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Preliminary Study to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
- Conditions
- Peripheral Arterial Disease
- Being tested
- LineMatrix® Biological Vascular Graft
- Medical subject headings
- Peripheral Arterial Disease
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 for Infrarenal Arterial Bypass or Replacement
| Study group | Role | What they receive |
|---|---|---|
| LineMatrix® Biological Vascular Graft | Experimental | Not described Receives: Device: LineMatrix® Biological Vascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate at 6 months postoperatively
Defined as: the proportion of vascular graft patency without additional intervention.
Measured: 6 Months
Secondary outcomes (6)
Primary patency rate at 3 months and 12 months postoperatively
Defined as: the proportion of vascular graft patency without additional intervention.
Measured: 3-12 Months
Cumulative patency rate at 3 months, 6 months, and 12 months
Defined as the proportion of subjects whose artificial vascular bypass graft has not been abandoned from the date of bypass establishment up to 12 months postoperatively.
Measured: 3-12 Months
Amputation-free survival rate at 6 months postoperatively
Defined as: the proportion of subjects without above-ankle amputation or death from any cause at 6 months postoperatively.
Measured: 6 Months
Limb salvage rate at 6 months postoperatively
Defined as: the proportion of subjects without above-ankle amputation at 6 months postoperatively.
Measured: 6 Months
Surgical success rate
Defined as: successful completion of surgery using the trial device, without device-related serious adverse events during the perioperative period.
Measured: 1 Month
Performance evaluation of biological vascular graft
- 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.
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 posted29 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Humatrix Medical Technology (Suzhou) Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733076
- Sponsor's protocol ID
- HMX-002-CTP-01
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
- ClinicalTrials.gov ID
- NCT07733076
- Acronym / sponsor ID
- HMX-002-CTP-01
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Humatrix Medical Technology (Suzhou) Co., LTD
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 29 Jul 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.
Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LineMatrix® Biological Vascular Graft | Experimental | Device: LineMatrix® Biological Vascular Graft |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.Adults aged ≥18 and ≤80 years, inclusive;
- 2.Patients evaluated by the investigative staff as requiring infra-renal arterial bypass or arterial replacement, including but not limited to: ischemia, infection, trauma, arterial rupture;
- 3.For ischemic limbs requiring infra-inguinal arterial bypass, Rutherford stage 3-6; Ankle-Brachial Index (ABI) ≤0.6; Preoperative imaging showing at least one below-knee artery vessel patent to the ankle with good runoff; No whole-segment healthy great saphenous vein available;
- 4.Patients who are able to communicate effectively with investigative staff, competent and willing to give written informed consent, and are able to comply with entire study procedures including all scheduled follow-up visits.
Key exclusion criteria (17 listed)
- 1.Distal target artery diameter <2.5mm;
- 2.Known or suspected allergy to contrast media, anticoagulant/antiplatelet drugs, alcohol, or bovine-derived products;
- 3.Hemoglobin <60g/L, platelet count <60×10⁹/L;
- 4.Left ventricular ejection fraction <30%;
- 5.Severe cardiac disease: including New York Heart Association (NYHA) Scale III-IV severe heart failure, or a history of myocardial infarction, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina within 3 months;
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 for Infrarenal Arterial Bypass or Replacement | Device | LineMatrix® Biological Vascular Graft |
Primary outcome
Primary patency rate at 6 months postoperatively
Time frame: 6 Months
Defined as: the proportion of vascular graft patency without additional intervention.
6 secondary outcomes
Primary patency rate at 3 months and 12 months postoperatively
Time frame: 3-12 Months
Cumulative patency rate at 3 months, 6 months, and 12 months
Time frame: 3-12 Months
Amputation-free survival rate at 6 months postoperatively
Time frame: 6 Months
Limb salvage rate at 6 months postoperatively
Time frame: 6 Months
Surgical success rate
Time frame: 1 Month
Performance evaluation of biological vascular graft
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing LineMatrix® Biological Vascular Graft in people with Peripheral Arterial Disease, run by Shanghai Zhongshan Hospital.
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 4 inclusion and 17 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Weiguo Fu (+8613801760929, fu.weiguo@zs-hospital.sh.cn), 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). 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 30 Jul 2026.