Идёт набор NCT03936647

The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices

Без фазы С лечением Intracranial Aneurysm Brain Aneurysm Unruptured Cerebral Aneurysm Ruptured Cerebral Aneurysm

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 clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling, WEB embolization device.
Кому может быть актуально: Состояния в реестре: Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm. 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: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a number of treatment adjuncts have been designed. One particularly promising innovation is the WEB (Woven EndoBridge), which permits placement of an intra-saccular flow diverting mesh across the aneurysm neck, but which does not require anti-platelet agent therapy. Currently, which treatment option leads to the best outcome for patients with WNBA remains unknown. There is a need to offer treatment with the WEB within the context of a randomized care trial, to patients currently presenting with aneurysms thought to be suitable for the WEB.

Вмешательства

Процедура surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling
Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.
Устройство WEB embolization device
WEB embolization device

Первичные конечные точки

Number of participants with imaging showing that index aneurysm has reached complete or near occlusion [Срок оценки: 1 year from procedure]
Number of patients with a modified Rankin Score (mRS) below or equal to 2 [Срок оценки: 1 year from procedure]

Вторичные конечные точки (9)

Number of participants with an interim modified Rankin Scale (mRS) below or equal to 2 [Срок оценки: within 1 week post-procedure, 1-3 months, and 12 months post-treatment]
Number of successful deployment of WEB device, coils or successful microsurgical, clipping, along with judgement of patency of parent arteries using imaging (depending on treatment received) [Срок оценки: within 1 hour from procedure]
Number of incidences of successful or unsuccesful patency of parent arteries using imaging [Срок оценки: within 1 hour from procedure]
Number of peri-operative complications [Срок оценки: ≥5 days]
Number of aneurysm re-occurrences, (re-)rupture, or incomplete occlusion based on angiographic imaging [Срок оценки: 12 +/- 2 months]
Hospitalization time [Срок оценки: up to first post-procedure visit (around 1 month)]
Incidence of discharge destination by type [Срок оценки: up to first post-procedure visit (around 1 month)]
Number of participants with stroke, neurological symptom or sign [Срок оценки: within 12 +/- 2 months]
Number of index aneurysms necessitating or having received retreatment due to re-occurence [Срок оценки: Within 12 +/- 2 months]

Критерии участия

Критерии включения

patient with an intracranial aneurysm in whom WEB is considered an appropriate therapeutic option by the participating clinician
aneurysm of maximum diameter of 4-11 mm
may include (but are not restricted to) saccular bifurcation aneurysms of the middle cerebral artery, basilar bifurcation, carotid terminus, or anterior communicating artery aneurysms
Recurring, persistent aneurysm after previous treatment can be included so long as the treating physician judges the aneurysm morphology to be appropriate.
Ruptured aneurysms with WFNS ≤ 3