A237 IntraCranial atherosclerosis related large-vessel occlusion treated with urgent stenting – a pragmatic, international, multicentre, randomized trial (ICARUS)
<h3>Introduction</h3> Whether rescue stenting (RS) of failed reperfusion after endovascular therapy (EVT) due to intracranial atherosclerosis disease (ICAD) in acute ischemic stroke patients with large vessel occlusions (LVO) is beneficial remains a matter of debate. As these patients suffer from substantial morbidity and mortality, randomized-controlled evidence is warranted. <h3>Aim of Study</h3> The primary objective is to determine whether patients experiencing an AIS due to an ICAD related LVO and failed reperfusion after up to 3 EVT passes have superior functional outcome (measured with the modified Rankin Scale (mRS) at 90 days) when treated with RS compared to patients treated with EVT alone. Secondary objectives are to study causes of mortality, dependency, cognitive function, and quality of life. <h3>Method</h3> The trial is conducted at over 50 academic tertiary care centres in Europe to evaluate RS in patients with LVO and failed reperfusion due to ICAD. Up to four hundred ninety-eight LVO patients with failed reperfusion due to ICAD will be randomly assigned in a 1:1 ratio to undergo RS or continuation of EVT. Outcomes will be evaluated at 24 hours, discharge, 90 days and 365 days after the stroke. Main safety outcome will be symptomatic intracranial hemorrhage. <h3>Results</h3> ICARUS started recruitment in March 2025 and until now 1 patient has been recruited. We estimate to finish recruitment by March 2028. <h3>Conclusion</h3> ICARUS will provide evidence for the effects of RS in LVO stroke patients with failed reperfusion due to ICAD. <h3>ClinicalTrials</h3> <b>gov Identifier:</b>NCT06472336 <b>Current trial status (14 April 2025):</b> 1/498 patients randomised <h3>Conflict of Interest</h3> No
Authors
- Alex Brehm (ORCID: https://orcid.org/0000-0002-1630-6210)
- Urs Fischer (ORCID: https://orcid.org/0000-0003-0521-4051)
- Victoria Hellstern (ORCID: https://orcid.org/0000-0002-6332-4681)
- Nikki Rommers (ORCID: https://orcid.org/0000-0003-0311-5009)
- Johanna T Fifi (ORCID: https://orcid.org/0000-0001-7786-5668)
- M. Ribó (ORCID: https://orcid.org/0000-0002-9931-4557)
- F. van den Bergh (ORCID: https://orcid.org/0000-0002-4935-514X)
- Aristeidis H. Katsanos (ORCID: https://orcid.org/0000-0002-6359-0023)
- Markus Moehlenbruch
- Jeffrey L. Saver (ORCID: https://orcid.org/0000-0001-9141-2251)
- Jennifer Linn (ORCID: https://orcid.org/0000-0003-0797-2761)
- Vítor Mendes Pereira (ORCID: https://orcid.org/0000-0002-6804-3985)
- Juan F. Arenillas (ORCID: https://orcid.org/0000-0001-7464-6101)
- Anne‐Christine Januel
- Marios Psychogios
Institutions
- Universidad de Valladolid (ES)
- St. Michael's Hospital (CA)
- University of California, Los Angeles (US)
- Heidelberg University (DE)
- Kantonsspital St. Gallen (CH)
- Hamilton General Hospital (CA)
- University Hospital of Bern (CH)
- University Hospital Heidelberg (DE)
- University Hospital of Basel (CH)
- Mount Sinai Hospital (US)
- Universitair Ziekenhuis Brussel (BE)
- Vall d'Hebron Hospital Universitari (ES)
- University Hospital Carl Gustav Carus (DE)
Publication Details
- Published
- 2025-09-01
- DOI
- https://doi.org/10.1136/jnis-2025-esmint.164
- Primary Topic
- Cerebrovascular and Carotid Artery Diseases
- Type
- article
- Field-Weighted Citation Impact
- 0.00