Can a Lab-Grown artery graft outlast current options?
NCT ID NCT07733076
First seen Jul 29, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests a new biological graft, LineMatrix®, for replacing or bypassing damaged arteries in the lower body. About 15 adults with peripheral artery disease or other artery damage will receive the graft during surgery. Researchers will track how well the graft stays open without additional procedures over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a biological vascular graft called LineMatrix® used to replace or bypass damaged arteries
- What this could lead to
- If successful, this graft could offer a more durable option for artery repair, reducing the need for repeat surgeries.
- What could go wrong
- This is a very small, early study with only 15 participants, so results may not apply widely. Risks include graft blockage, infection, or failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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