Randomized Controlled TrialWorld Neurosurg
doi: 10.1016/j.wneu.2021.12.083. Epub 2021 Dec 28.
Middle Cerebral Artery Aneurysm Trial (MCAAT): A Randomized Care Trial Comparing Surgical and Endovascular Management of MCA Aneurysm Patients
Tim E Darsaut 1, Michael B Keough 1, William Boisseau 2, J Max Findlay 1, Michel W Bojanowski 3, Chiraz Chaalala 3, Daniela Iancu 2, Alain Weill 2, Daniel Roy 2, Laurent Estrade 4, Jean-Paul Lejeune 5, Anne-Christine Januel 6, Andrew P Carlson 7, Eric Sauvageau 8, Hosam Al-Jehani 9, Kirill Orlov 10, Sorin Aldea 11, Michel Piotin 12, Thomas Gaberel 13, Guylaine Gevry 2, Jean Raymond 2
Affiliations expand
- PMID: 34971833
- DOI: 10.1016/j.wneu.2021.12.083
Abstract
Background: Whether the best management of middle cerebral artery (MCA) aneurysm patients is surgical or endovascular remains uncertain, with little evidence to guide decision-making. A randomized care trial offering MCA aneurysm patients a 50% chance of surgical and a 50% chance of endovascular management may optimize outcomes in the presence of uncertainty.
Methods: The Middle Cerebral Artery Aneurysm Trial (MCAAT) is an investigator-initiated, multicenter, parallel group, prospective, 1:1 randomized controlled clinical trial. All adult patients with MCA aneurysms, ruptured or unruptured, amenable to surgical and endovascular treatment can be included. The composite primary outcome is “Treatment Success”: (i) occlusion or exclusion of the aneurysm using the allocated treatment modality; (ii) no intracranial hemorrhage during follow-up; (iii) no retreatment of the target aneurysm during follow-up, (iv) no residual aneurysm on angiographic follow-up; and (v) independence (mRS <3) at 1 year. The trial tests 2 versions of the same hypothesis (one for ruptured and one for unruptured MCA aneurysm patients): Surgical management will lead to a 15% absolute increase in the proportion of patients reaching Treatment Success from 55% to 70% (ruptured) or from 75% to 90% (unruptured aneurysm patients) compared with endovascular treatment (any method). In this pragmatic trial, outcome evaluations are by treating physicians, except for 1-year angiographic results which will be core lab assessed. The trial will be monitored by an independent data safety monitoring committee to assure safety of participants. MCAAT is registered at clinicaltrials.gov: NCT05161377.
Conclusions: Patients with MCA aneurysms can be optimally managed within a care trial protocol.
Keywords: Endovascular management; MCA aneurysm; Randomized trial; Surgical clipping.
Copyright © 2021 Elsevier Inc. All rights reserved.
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