IMPRoving Outcomes in Vascular DisEase - 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: TEVAR, Guideline directed medical therapy and surveillance of dissection.
- Кому может быть актуально
- Состояния в реестре: Type B Aortic Dissection. Базовые параметры: от 21 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, Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Обзор
The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.
Подробное описание
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.
Вмешательства
- Процедура TEVAR
Thoracic endovascular aortic repair - Другое Guideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Первичные конечные точки
- All-cause death or major aortic complications (MAC) [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
Вторичные конечные точки (12)
- Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol) [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Cumulative incidence of cardiovascular (CV) hospitalizations [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Mean number of cardiovascular (CV) hospitalizations [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of cardiovascular death [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of all-cause death [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Cumulative incidence of major aortic complications (MAC) [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of stroke [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of paraplegia or paraparesis [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of vascular access injury requiring surgical repair [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of aortobronchial / aortoesophageal fistula [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of retrograde type A dissection [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of aortic-related death [Срок оценки: Last follow-up timepoint. Differential follow-up with median of about 4 years]
Критерии участия
Критерии включения
- Age > 21 years
- Patients with a Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion syndrome (renal, mesenteric, or extremity) who are within 48 hours to 6 weeks after start of index admission for their type B dissection
- Ability to provide written informed consent
- Investigator believes anatomy is suitable for TEVAR
Критерии исключения
- Ongoing systemic infection
- Pregnant or planning to become pregnant in the next 3 months
- Life expectancy related to non-aortic conditions < 2 years
- Unwilling or unable to comply with all study procedures
- Known patient history of genetic aortopathy
- Penetrating Aortic Ulcer without concomitant uTBAD
- Intramural hematoma without concomitant uTBAD
- Iatrogenic (traumatic) aortic dissection
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
США · 61 центр
- University of Alabama at Birmingham — Birmingham
- Honorhealth — Phoenix
- Memorial Care Long Beach Medical Center — Long Beach
- Keck Medical Center of USC — Los Angeles
- University of California San Diego — San Diego
- University of California — San Francisco
- Stanford University Medical Center — Stanford
- University of Colorado Denver — Aurora
- … и ещё 53 центра
Канада · 2 центра
- CHUM - Centre hospitalier de l'Universite de Montreal — Montreal
- McGill University Medical Center — Montreal
Идентификаторы
NCT: NCT06087029 · Pro00113329 · 4UH3HL165017-02 · 5U24HL165029-02