1. MR CLEAN-LATE, a multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands for late arrivals
- Author
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Pirson, F.A.V., Hinsenveld, W.H., Goldhoorn, R.J.B., Staals, J., Ridder, I.R. de, Zwam, W.H. van, Walderveen, M.A.A. van, Nijeholt, G.J.L.A., Uyttenboogaart, M., Schonewille, W.J., Lugt, A. van der, Dippel, D.W.J., Roos, Y.B.W.E.M., Majoie, C.B.L.M., Oostenbrugge, R.J. van, MR CLEAN LATE Investigators, Neurology, ACS - Atherosclerosis & ischemic syndromes, ANS - Neurovascular Disorders, Radiology and Nuclear Medicine, ACS - Microcirculation, Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Radiology & Nuclear Medicine, Klinische Neurowetenschappen, MUMC+: MA Niet Med Staf Neurologie (9), RS: Carim - B05 Cerebral small vessel disease, MUMC+: MA AIOS Neurologie (9), MUMC+: MA Med Staf Spec Neurologie (9), Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: Carim - B06 Imaging, MUMC+: Hersen en Zenuw Centrum (3), MUMC+: MA Neurologie (3), and RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience
- Subjects
Intracranial Anterior Circulation ,medicine.medical_specialty ,Population ,Acute ischemic stroke ,Medicine (miscellaneous) ,Perfusion scanning ,Brain Ischemia ,law.invention ,Study Protocol ,Randomized controlled trial ,Modified Rankin Scale ,law ,Occlusion ,Clinical endpoint ,Humans ,Multicenter Studies as Topic ,Medicine ,Pharmacology (medical) ,Endovascular treatment ,education ,Ischemic Stroke ,Netherlands ,Randomized Controlled Trials as Topic ,Thrombectomy ,lcsh:R5-920 ,education.field_of_study ,medicine.diagnostic_test ,business.industry ,Endovascular Procedures ,Stroke ,Treatment Outcome ,Angiography ,Late arrivals ,Radiology ,lcsh:Medicine (General) ,business - 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 insight into whether EVT is safe and effective for patients treated between 6 and 24 h from time last known well after selection based on the presence of collateral flow on CTA. Trial registration NL58246.078.17, ISRCTN19922220, Registered on 11 December 2017
- Published
- 2021