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Идёт набор NCT06199401

Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery

Без фазы С лечением Type A Aortic Dissection Complication of Surgical Procedure Aortic Diseases

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: Vascular Grafts Eversion and Built-in Technique(XJ-Procedure).
Кому может быть актуально
Состояния в реестре: Type A Aortic Dissection, Complication of Surgical Procedure, Aortic Diseases. Базовые параметры: 18 лет — 70 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

Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery (ADVANCED-XJ-Ⅱ): A National, Multi-center, Open-label, Randomized, Controlled, Blinded-end Point Trial

Обзор

This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, "Sun's procedure" combined with "XJ-Procedure" in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.

Подробное описание

In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with the XJ-procedure. The patients in the control group will also undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with each center. The primary outcome event is all-cause mortality within 12 months after surgery. Secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (during hospitalization, follow-up 3 months, 6 months, 12 months).

Вмешательства

  • Процедура Vascular Grafts Eversion and Built-in Technique(XJ-Procedure)
    A 1.5-2cm wide bovine pericardial patch and graft ring will be placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft will be intermittently sutured to full layers of aortic vascular with 2-0 pad polyester suture. Finally, the eversion and aortic wall will be continuously sutured together in one more turn.

Первичные конечные точки

  • All-cause mortality [Срок оценки: 12 months follow-up]
Вторичные конечные точки (5)
  • Change of incidence of residual aortic root dissection [Срок оценки: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up]
  • Change of incidence of second surgery for hemostasis due to aortic root hemorrhage [Срок оценки: About 20 days (during hospitalization)]
  • Change of incidence of anastomotic pseudoaneurysms during hospitalization [Срок оценки: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up]
  • Change of incidence of severe residual aortic valve regurgitation [Срок оценки: About 20 days (during hospitalization), at the 3 months, 6 months, and 12 months follow-up]
  • Change of incidence of MACCE [Срок оценки: About 20 days (during hospitalization), at the 3 months,6 months, and 12 months follow-up]

Критерии участия

Критерии включения

  • Age 18-70 years;
  • Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".

Критерии исключения

  • Severe aortic root involvement (root diameter >45 mm, root tear, severe destruction of the aortic root, combined valve disease);
  • Combined coronary artery disease requiring concomitant coronary revascularization;
  • Prior aortic or cardiac surgery;
  • Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities >12 h;
  • Preoperative combination of severe single or multiple organ failure;
  • Pregnant women;
  • Refused to sign the informed consent form and refused to participate in this study.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • First Affiliated Hospital of Xi'an Jiaotong University — Сиань

Идентификаторы

NCT: NCT06199401 · XJTU1AF2023LSYY-006-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗