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

Официальное название

A Preliminary Study to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement

Обзор

Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement

Вмешательства

• Устройство LineMatrix® Biological Vascular Graft
  LineMatrix® Biological Vascular Graft for Infrarenal Arterial Bypass or Replacement

Первичные конечные точки

• Primary patency rate at 6 months postoperatively [Срок оценки: 6 Months]

Вторичные конечные точки (6)

• Primary patency rate at 3 months and 12 months postoperatively [Срок оценки: 3-12 Months]
• Cumulative patency rate at 3 months, 6 months, and 12 months [Срок оценки: 3-12 Months]
• Amputation-free survival rate at 6 months postoperatively [Срок оценки: 6 Months]
• Limb salvage rate at 6 months postoperatively [Срок оценки: 6 Months]
• Surgical success rate [Срок оценки: 1 Month]
• Performance evaluation of biological vascular graft [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07733076 · HMX-002-CTP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗