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Набор скоро начнётся NCT07402252

Effectiveness and Safety of a Type A Dissection Total Endovascular Reconstruction System in Promoting Favorable Distal Aortic Remodeling

Без фазы С лечением Residual Dissection After Repair for Type A Aortic Dissection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: surgical treatment, Standard of Care (Investigator Choice).
Кому может быть актуально
Состояния в реестре: Residual Dissection After Repair for Type A Aortic Dissection. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Effectiveness and Safety of a Type A Dissection Total Endovascular REconstruction System in Promoting Favorable Distal AOrtic ReModeling After Total Arch Replacement With Frozen Elephant Trunk for Type A Aortic Dissection: A Prospective, Multicenter, Randomized Controlled Trial

Обзор

This is a prospective, multicenter, randomized controlled clinical study. A total of 198 eligible subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Study Group or the Control Group. Subjects in the Study Group will receive surgical treatment using the study device (Type A Dissection Total Endovascular Reconstruction System) in addition to standard medical therapy following the Total Arch Replacement with Frozen Elephant Trunk. Subjects in the Control Group will continue standard medical therapy without surgical treatment using the study device following Total Arch Replacement with Frozen Elephant Trunk. Clinical follow-ups will be conducted at 30 days (±7 days), 6 months (±30 days), and 12 months (±30 days) post-enrollment to evaluate the effectiveness and safety of the study device. After all subjects complete the 12-month (±30 days) follow-up, a statistical analysis will be performed and the results will be submitted for the study device registration application. Long-term follow-up will continue for 2-5 years post-enrollment.

Вмешательства

  • Устройство surgical treatment
    Endovascular repair with study device following the Total Arch Replacement with Frozen Elephant Trunk for Stanford Type A Aortic Dissection.
  • Препарат Standard of Care (Investigator Choice)
    Standard medical therapy (e.g., blood pressure and heart rate control)

Первичные конечные точки

  • Change in False Lumen Volume of the Distal Aortic Dissection at 12 months [Срок оценки: 12 months (±30 days) post-enrollment]
  • The incidence of major adverse events (MAEs) within 30 days [Срок оценки: 30 days (±7 days) after enrollment]
Вторичные конечные точки (12)
  • Procedure Success Rate (%) (Immediate post-procedure) (Study Group only) [Срок оценки: Immediately post procedure]
  • Treatment Success Rate (%) (12 months) (Study Group only) [Срок оценки: 12 months (±30 days) after enrollment]
  • Change in True Lumen Volume of the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
  • Change in False Lumen Volume of the Distal Aortic Dissection (at 30 days, 6 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), and 2-5 years (±30 days) after enrollment]
  • Change in Maximum Diameter of the Distal Aorta (True + False Lumen) (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
  • Thrombosis Status of the False Lumen in the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
  • Rate of Secondary Intervention Related to the Distal Aortic Dissection (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
  • Survival Rate (6, 12 months, 2-5 years) [Срок оценки: 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
  • Incidence of MAE (6, 12 months, 2-5 years) [Срок оценки: 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]
  • Incidence of Paraplegia/Spinal Cord Ischemia (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
  • Incidence of Acute Kidney Injury (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment.]
  • Incidence of Stroke (at 30 days, 6, 12 months, 2-5 years) [Срок оценки: 30 days (±7 days), 6 months (±30 days), 12 months (±30 days), and 2-5 years (±30 days) after enrollment]

Критерии участия

Критерии включения

  • Age ≥18 years, male or female.
  • Within 90 days of onset of Stanford Type A Aortic Dissection and 30 days post Total Arch Replacement with Frozen Elephant Trunk treatment (assessed via CTA at 30±7 days post open surgery):
  • Presence of any intimal tear in the residual dissection of the thoracic aorta and the false lumen is not completely thrombosed.
  • The intercostal arteries in the segment of the residual thoracic aortic dissection are primarily supplied by the false lumen (number of intercostal arteries supplied by false/mixed lumen > number supplied by true lumen; only intercostal arteries filled with contrast agent are considered).
  • False lumen volume in the thoracic aorta distal to the frozen elephant trunk stent graft is >50% of the total aortic lumen volume.
  • Voluntarily participate in this study and provide signed informed consent.

Критерии исключения

  • Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery.
  • No left subclavian artery revascularization during the open surgery.
  • Presence of severe endoleak, or residual dissection expansion ≥55mm, or distal stent graft-induced new entry.
  • History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure.
  • Previous history of descending thoracic or abdominal aortic surgery.
  • Lack of suitable vascular access.
  • Known allergy to components of the study device (e.g., Nitinol) or contrast agent.
  • Renal insufficiency (creatinine >2.5 times the upper limit of normal) or requiring long-term regular dialysis.
  • Severe liver dysfunction (Child-Pugh Class C).
  • Active bleeding, coagulation disorders, thrombocytopenia (platelet count <50×109/L), or refusal of blood transfusion.
  • Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure.
  • Life expectancy less than 12 months (due to conditions other than aortic dissection).
  • Known or suspected connective tissue degenerative disease, or family history of aortic dissection.
  • Pregnant or lactating women.
  • Concurrent participation in other drug or medical device clinical studies.
  • Subjects deemed unsuitable for participating the study by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT07402252 · CX2025001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗