• World Neurosurg · Sep 2020

    Clinical Trial

    Comprehensive Aneurysm Management (CAM): An all-inclusive care trial for unruptured intracranial aneurysms.

    • Tim E Darsaut, Hubert Desal, Christophe Cognard, Anne-Christine Januel, Romain Bourcier, Grégoire Boulouis, Shiva Shankar Jai Jai JJ Department of Radiology, University of Manitoba, Winnipeg, Manitoba, Canada., J Max Findlay, Jeremy L Rempel, Robert Fahed, Edoardo Boccardi, Luca Valvassori, Elsa Magro, Jean-Christophe Gentric, Michel W Bojanowski, Chiraz Chaalala, Daniela Iancu, Daniel Roy, Alain Weill, Ange Diouf, Guylaine Gevry, Miguel Chagnon, and Jean Raymond.
    • University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division Crosurgery, Edmonton, Alberta, Canada.
    • World Neurosurg. 2020 Sep 1; 141: e770-e777.

    BackgroundIn the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain.MethodsComprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years.ResultsThe CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study.ConclusionsPatients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.Copyright © 2020 Elsevier Inc. All rights reserved.

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