Title :

Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ≤5) and large vessel occlusion: the MOSTE multicenter, randomized, clinical trial protocol.

Author(s) :

Arquizan, Caroline [Auteur]
Hôpital Gui de Chauliac [CHU Montpellier]
Lapergue, Bertrand [Auteur]
Hôpital Foch [Suresnes]
Gory, Benjamin [Auteur]
Département de neuroradiologie diagnostique et thérapeutique [CHRU Nancy]
Labreuche, Julien [Auteur]
Institute for Translational Research in Inflammation - U 1286 [INFINITE]
Henon, Hilde [Auteur]
Lille Neurosciences & Cognition (LilNCog) - U 1172
Albucher, Jean-François [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Sibon, Igor [Auteur]
Centre Hospitalier Universitaire de Bordeaux [CHU Bordeaux]
Turc, Guillaume [Auteur]
Centre Hospitalier Sainte Anne [Paris]
Richard, Sebastien [Auteur]
Service de neurologie [CHRU Nancy]
Nouri, Nasreddine [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Cognard, Christophe [Auteur]
Centre Hospitalier Universitaire de Toulouse [CHU Toulouse]
Marnat, Gauthier [Auteur]
CHU de Bordeaux Pellegrin [Bordeaux]
Naggara, Olivier [Auteur]
Centre Hospitalier Sainte Anne [Paris]
Di Maria, Federico [Auteur]
Hôpital Foch [Suresnes]
Duhamel, Alain [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Jovin, Tudor [Auteur]
Cooper Medical School of Rowan University [Camden] [CMSRU]
Costalat, Vincent [Auteur]
Neuroradiologie [Hôpital Gui de Chauliac]

Journal title :

International Journal of Stroke

Abbreviated title :

Int J Stroke

Pages :

17474930231186039

Publication date :

2023-06-23

ISSN :

1747-4949

English keyword(s) :

Acute stroke therapy
clinical trial
mechanical thrombectomy
ischemic stroke
large vessel occlusion
NIHSS 0-5

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Rationale: Mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke secondary to large vessel occlusion (LVO) of the anterior circulation. Conversely, its benefit in patients ...
Show more >Rationale: Mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke secondary to large vessel occlusion (LVO) of the anterior circulation. Conversely, its benefit in patients with National Institutes of Health Stroke Scale (NIHSS) score ⩽ 5 is unproven. Aim: To demonstrate the superiority of immediate MT plus best medical treatment (BMT) compared to BMT (with secondary MT in case of deterioration) for increasing the rate of modified Rankin Scale (mRS) score ⩽ 1 at 90 days after minor stroke (NIHSS score ⩽ 5) and anterior circulation LVO. Sample size estimates: To detect an absolute increase of 10% (80% power) in the 90-day mRS score = 0–1 rate in the MT + BMT group, by assuming an mRS score = 0–1 rate of 60% in the BMT group and by considering two interim efficacy/futility analyses (after study completion by 274 and 548 patients), 824 patients must be included by 36 centers in France, Spain, and the USA. Methods and design: MOSTE is an international, multicenter, prospectively randomized into two parallel (1:1) arms, open-label, with blinded endpoint trial. Eligibility criteria are diagnosis of acute ischemic stroke within 23 h of last-seen-well, NIHSS score ⩽ 5, and LVO in the anterior circulation (intracranial internal carotid artery, M1 or M1-M2 segment of the middle cerebral artery). Study outcomes: The primary endpoint is the rate of excellent outcome at day 90 (mRS score = 0–1). Secondary endpoints include the rates of 90-day mRS score = 0–2 and score = 0, NIHSS score change, secondary MT, revascularization and infarct volume growth at 24 h, and quality of life and cognitive function at day 90. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and rapid NIHSS score worsening) are recorded. Discussion: The MOSTE trial will determine MT efficacy and safety in patients with minor stroke and LVO in the anterior circulation.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• Lille Neurosciences & Cognition (LilNCog) - U 1172
• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2023-11-15T01:46:24Z
2024-04-02T09:04:57Z