MR CLEAN-LATE, a multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands for late arrivals: study protocol for a randomized controlled trial

Abstract Background Endovascular therapy (EVT) for acute ischemic stroke due to proximal occlusion of the anterior intracranial circulation, started within 6 h from symptom onset, has been proven safe and effective. Recently, EVT has been proven effective beyond the 6-h time window in a highly selected population using CT perfusion or MR diffusion. Unfortunately, these imaging modalities are not available in every hospital, and strict selection criteria might exclude patients who could still benefit from EVT. The presence of collaterals on CT angiography (CTA) may offer a more pragmatic imagin... Mehr ...

Verfasser: F. A. V. ( Anne) Pirson
Wouter H. Hinsenveld
Robert-Jan B. Goldhoorn
Julie Staals
Inger R. de Ridder
Wim H. van Zwam
Marianne A. A. van Walderveen
Geert J. Lycklama à Nijeholt
Maarten Uyttenboogaart
Wouter J. Schonewille
Aad van der Lugt
Diederik W. J. Dippel
Yvo B. W. E. M. Roos
Charles B. L. M. Majoie
Robert J. van Oostenbrugge
on behalf of the MR CLEAN-LATE investigators
Dokumenttyp: Artikel
Erscheinungsdatum: 2021
Reihe/Periodikum: Trials, Vol 22, Iss 1, Pp 1-13 (2021)
Verlag/Hrsg.: BMC
Schlagwörter: Endovascular treatment / Thrombectomy / Acute ischemic stroke / Randomized controlled trial / Late arrivals / Medicine (General) / R5-920
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29173143
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.1186/s13063-021-05092-0

Abstract Background Endovascular therapy (EVT) for acute ischemic stroke due to proximal occlusion of the anterior intracranial circulation, started within 6 h from symptom onset, has been proven safe and effective. Recently, EVT has been proven effective beyond the 6-h time window in a highly selected population using CT perfusion or MR diffusion. Unfortunately, these imaging modalities are not available in every hospital, and strict selection criteria might exclude patients who could still benefit from EVT. The presence of collaterals on CT angiography (CTA) may offer a more pragmatic imaging criterion that predicts possible benefit from EVT beyond 6 h from time last known well. The aim of this study is to assess the safety and efficacy of EVT for patients treated between 6 and 24 h from time last known well after selection based on the presence of collateral flow. Methods The MR CLEAN-LATE trial is a multicenter, randomized, open-label, blinded endpoint trial, aiming to enroll 500 patients. We will investigate the efficacy of EVT between 6 and 24 h from time last known well in acute ischemic stroke due to a proximal intracranial anterior circulation occlusion confirmed by CTA or MRA. Patients with any collateral flow (poor, moderate, or good collaterals) on CTA will be included. The inclusion of poor collateral status will be restricted to a maximum of 100 patients. In line with the current Dutch guidelines, patients who fulfill the characteristics of included patients in DAWN and DEFUSE 3 will be excluded as they are eligible for EVT as standard care. The primary endpoint is functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score. Treatment effect will be estimated with ordinal logistic regression (shift analysis) on the mRS at 90 days. Secondary endpoints include clinical stroke severity at 24 h and 5–7 days assessed by the NIHSS, symptomatic intracranial hemorrhage, recanalization at 24 h, follow-up infarct size, and mortality at 90 days, Discussion This study will provide ...