LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement

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.