Endovascular treatment of acute ischemic stroke in the Netherlands for late arrivals

Conditions

Acute ischemic stroke due to an intracranial large vessel occlusion of the anterior circulation Circulatory System

Susanne G. H. Olthuis, Florentina M.E. Pinckaers, M M Q Robbe, Inger R. de Ridder, Jan W. Hoving et al. (100 authors)

JAMA Neurology2025-05-053 citations

10.1001/jamaneurol.2025.0716

Collateral-based selection for endovascular treatment of acute ischaemic stroke in the late window (MR CLEAN-LATE): 2-year follow-up of a phase 3, multicentre, open-label, randomised controlled trial in the Netherlands.

Huijberts I, Pinckaers FME, Olthuis SGH, van Kuijk SMJ, Postma AA, Boogaarts HD, Roos YBWEM, Majoie CBLM, van der Lugt A, Dippel DWJ, van Zwam WH, van Oostenbrugge RJ, MR CLEAN-LATE investigators.

2024-06-2011 citations

10.1016/s1474-4422(24)00228-x

Endovascular treatment versus no endovascular treatment after 6-24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial.

Olthuis SGH, Pirson FAV, Pinckaers FME, Hinsenveld WH, Nieboer D, Ceulemans A, Knapen RRMM, Robbe MMQ, Berkhemer OA, van Walderveen MAA, Lycklama À Nijeholt GJ, Uyttenboogaart M, Schonewille WJ, van der Sluijs PM, Wolff L, van Voorst H, Postma AA, Roosendaal SD, van der Hoorn A, Emmer BJ, Krietemeijer MGM, van Doormaal PJ, Roozenbeek B, Goldhoorn RB, Staals J, de Ridder IR, van der Leij C, Coutinho JM, van der Worp HB, Lo RTH, Bokkers RPH, van Dijk EI, Boogaarts HD, Wermer MJH, van Es ACGM, van Tuijl JH, Kortman HGJ, Gons RAR, Yo LSF, Vos JA, de Laat KF, van Dijk LC, van den Wijngaard IR, Hofmeijer J, Martens JM, Brouwers PJAM, Bulut T, Remmers MJM, de Jong TEAM, den Hertog HM, van Hasselt BAAM, Rozeman AD, Elgersma OEH, van der Veen B, Sudiono DR, Lingsma HF, Roos YBWEM, Majoie CBLM, van der Lugt A, Dippel DWJ, van Zwam WH, van Oostenbrugge RJ, MR CLEAN-LATE investigators.

2023-03-29152 citations

10.1016/s0140-6736(23)00575-5

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.

Pirson FAVA, Hinsenveld WH, Goldhoorn RB, Staals J, de Ridder IR, van Zwam WH, van Walderveen MAA, Lycklama À Nijeholt GJ, Uyttenboogaart M, Schonewille WJ, van der Lugt A, Dippel DWJ, Roos YBWEM, Majoie CBLM, van Oostenbrugge RJ, MR CLEAN-LATE investigators.

2021-02-2447 citations

10.1186/s13063-021-05092-0

MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion-study protocol for a randomized clinical trial.

Treurniet KM, LeCouffe NE, Kappelhof M, Emmer BJ, van Es ACGM, Boiten J, Lycklama GJ, Keizer K, Yo LSF, Lingsma HF, van Zwam WH, de Ridder I, van Oostenbrugge RJ, van der Lugt A, Dippel DWJ, Coutinho JM, Roos YBWEM, Majoie CBLM, MR CLEAN-NO IV Investigators.

2021-02-1545 citations

10.1186/s13063-021-05063-5

Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design

Vicky Chalos, Rob A. van de Graaf, Bob Roozenbeek, Adriaan C.G.M. van Es, Heleen M. den Hertog et al. (100 authors)

Trials2020-07-1435 citations

10.1186/s13063-020-04514-9

Rationale and design for studying organisation of care for intra-arterial thrombectomy in the Netherlands: simulation modelling study

Maarten M.H. Lahr, Willemijn J Maas, Durk-Jouke van der Zee, Maarten Uyttenboogaart, Erik Buskens

BMJ Open2020-01-0111 citations

10.1136/bmjopen-2019-032754

Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch (MR ASAP): study protocol for a randomised controlled trial.

van den Berg SA, Dippel DWJ, Hofmeijer J, Fransen PSS, Caminada K, Siegers A, Kruyt ND, Kerkhoff H, de Leeuw FE, Nederkoorn PJ, van der Worp HB, MR ASAP Investigators.

2019-06-2618 citations

10.1186/s13063-019-3419-z

Interventions

Randomisation: web-based

permuted blocks. Backup by telephone. The control group will receive best medical management. The intervention group will receive endovascular treatment (EVT). All patients in the intervention group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of acute ischemic stroke 2. Caused by proximal intracranial anterior circulation occlusion (distal intracranial carotid artery or middle (M1/M2) cerebral artery confirmed by neuro-imaging (CTA or MRA) 3. Presence of poor*, moderate or good collateral flow as shown by neuroimaging (CTA) 4. CT or MRI ruling out intracranial hemorrhage 5. Start of IA treatment (groin puncture) possible between 6 and 24 hours after symptom onset or last seen well < 24 hours including wake-up strokes 6. A score of at least 2 on the NIH Stroke Scale 7. Age of 18 years or older *Inclusion and randomization will be restricted to patients with moderate or good collaterals when 100 patients with poor collaterals have been included in the study

Exclusion criteria

Exclusion criteria: 1. Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS >2 2. Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of large recent infarction on neuroimaging in the territory of the middle cerebral antery 3. Clinical evidence of hemorrhagic diathesis, confirmed by an INR > 3 and/or a platelet count 50 sec 4. Clearly demarcated hypodensity in >1/3 of the middle cerebral artery territory, consistent with current symptoms 5. Participation in trials other than current and MR ASAP

Design outcomes

Primary

Measure	Time frame
Functional outcome, measured by the modified Rankin Scale (mRS) at 90 days	—

Secondary

Measure	Time frame
1. Mortality at 90 days 2. Recanalization on CTA at 24 hours 3. Infarct size on non-contrast head CT (NCCT) at 5-7 days or just before discharge 4. Symptomatic intra-cranial hemorrhage according to the Heidelberg criteria at 24 hours, and 5-7 days after randomization 5. Clinical stroke severity, measured by the National Institutes of Health Stroke Scale score at 24 hours and 5-7 days after randomization	—

Measure

Time frame

1. Mortality at 90 days 2. Recanalization on CTA at 24 hours 3. Infarct size on non-contrast head CT (NCCT) at 5-7 days or just before discharge 4. Symptomatic intra-cranial hemorrhage according to the Heidelberg criteria at 24 hours, and 5-7 days after randomization 5. Clinical stroke severity, measured by the National Institutes of Health Stroke Scale score at 24 hours and 5-7 days after randomization

—

Countries

Netherlands

Outcome results

None listed