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Идёт набор NCT04747626

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Без фазы С лечением Thoracic Aortic Aneurysm Aortic Dissection Congenital Aortic Anomaly

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: B-SAFER.
Кому может быть актуально
Состояния в реестре: Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly. 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
США
Следующий шаг
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Обзор

A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.

Подробное описание

The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components.

Вмешательства

  • Устройство B-SAFER
    Simplified hybrid frozen elephant trunk repair will be performed by utilizing B-SAFER technique which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Первичные конечные точки

  • All-cause mortality [Срок оценки: Up to 30 days]
  • Stroke, excluding TIA [Срок оценки: Up to 30 days]
  • Paralysis, excluding paraparesis [Срок оценки: Up to 30 days]
  • Technical success [Срок оценки: 24 hours]
  • Patency of all graft/endograft components [Срок оценки: At hospital discharge or at 1 month]
  • Complete sealing of the aortic pathology [Срок оценки: At hospital discharge or 1 month]
Вторичные конечные точки (12)
  • Aortic related death [Срок оценки: Up to 36 months after the index procedure]
  • Pseudoaneurysm at the treatment sites [Срок оценки: Up to 36 months after the index procedure]
  • Unanticipated aortic or branch-related re-operation [Срок оценки: Up to 36 months after the index procedure]
  • Late Type I endoleak [Срок оценки: Up to 36 months after the index procedure]
  • Late Type III endoleak [Срок оценки: Up to 36 months after the index procedure]
  • Non-cardiac/non-aortic re-operations [Срок оценки: Up to 36 months after the index procedure]
  • Vocal Cord paralysis [Срок оценки: Up to 36 months after the index procedure]
  • Myocardial infarction [Срок оценки: Up to 36 months after the index procedure]
  • Respiratory failure [Срок оценки: Up to 36 months after the index procedure]
  • Renal failure requiring dialysis [Срок оценки: Up to 36 months after the index procedure]
  • Thromboembolic events [Срок оценки: Up to 36 months after the index procedure]
  • Failed patencies in graft, or endovascular stent-graft including the branch(es) [Срок оценки: Up to 36 months after the index procedure]

Критерии участия

Критерии включения

  • At least 18 years of age
  • Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study.
  • Expected life expectancy of greater than two years after repair
  • Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair

Критерии исключения

  • Subject is unfit for open surgical repair involving circulatory arrest
  • Subject is comatose or suffering from irreversible severe brain malperfusion
  • Subject has known sensitivity to components of the devices
  • Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
  • Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study
  • Subject has an uncorrectable bleeding anomaly
  • Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure
  • Subject is pregnant

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

США · 1 центр
  • Cleveland Clinic — Cleveland

Публикации

  • Roselli EE, Vargo PR, Bakaeen F, Koprivanac M, Burns D, Kuramochi Y, Gillinov M; B-SAFER Investigators. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. J Thorac Cardiovasc Surg. 2024 Sep;168(3):746-756. doi: 10.1016/j.jtcvs.2023.09.069. Epub 2023 Oct 5. PMID 37802330

Идентификаторы

NCT: NCT04747626 · G200342

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗