Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial

Louise Maes; Theodora Van Elk; Anne van der Meij; Femke Roelofs; Kris Bogaerts; Reinoud PH Bokkers; Gert J de Borst; Heleen M den Hertog; Diederik Wj Dippel; Olivier François; Noémie Ligot; Hester F Lingsma; Charles Blm Majoie; Jo Pp Peluso; Illario Tancredi; Ido R van den Wijngaard; Aad van der Lugt; Laetitia Yperzeele; Clark J Zeebregts; Paul J Nederkoorn; Robin Lemmens; Maarten Uyttenboogaart

doi:10.1177/23969873251319941

Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial

Louise Maes, Theodora Van Elk, Anne van der Meij, Femke Roelofs, Kris Bogaerts, Reinoud PH Bokkers, Gert J de Borst, Heleen M den Hertog, Diederik Wj Dippel, Olivier François, Noémie Ligot, Hester F Lingsma, Charles Blm Majoie, Jo Pp Peluso, Illario Tancredi, Ido R van den Wijngaard, Aad van der Lugt, Laetitia Yperzeele, Clark J Zeebregts, Paul J NederkoornRobin Lemmens, Maarten Uyttenboogaart^*

^*Corresponding author for this work

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Abstract

BACKGROUND: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.

STUDY DESIGN: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial. Patients with a computed tomography angiography proven intracranial LVO in the anterior circulation and ipsilateral proximal carotid artery stenosis (⩾50%) or occlusion of presumed atherosclerotic origin will be randomized to either immediate CAS during EVT or to EVT followed by a deferred strategy, which may include carotid endarterectomy (CEA), CAS, or medical management. CASES will be conducted in 27 EVT centers in Belgium and the Netherlands. A total of 600 patients will be included.

STUDY OUTCOMES: The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes include excellent (mRS 0-1) and good (mRS 0-2) functional outcome at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 h and 5-7 days, recanalization, infarct volume at 24 h, ischemic stroke recurrence, carotid artery re-occlusion, symptomatic intracranial hemorrhage, and mortality.

SUMMARY: This study will provide high-quality randomized data on the efficacy and safety of immediate CAS in patients undergoing EVT for acute ischemic stroke due to a tandem lesion.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06511089; ISRCTN 14956654.

Original language	English
Journal	European Stroke Journal
DOIs	https://doi.org/10.1177/23969873251319941
Publication status	E-pub ahead of print - 16-Feb-2025

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Maes, L., Van Elk, T., van der Meij, A., Roelofs, F., Bogaerts, K., Bokkers, R. PH., de Borst, G. J., den Hertog, H. M., Dippel, D. W., François, O., Ligot, N., Lingsma, H. F., Majoie, C. B., Peluso, J. P., Tancredi, I., van den Wijngaard, I. R., van der Lugt, A., Yperzeele, L., Zeebregts, C. J., ... Uyttenboogaart, M. (2025). Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial. European Stroke Journal. Advance online publication. https://doi.org/10.1177/23969873251319941

@article{f8834074a2cb49478a89e98267875345,

title = "Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial",

abstract = "BACKGROUND: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.STUDY DESIGN: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial. Patients with a computed tomography angiography proven intracranial LVO in the anterior circulation and ipsilateral proximal carotid artery stenosis (⩾50%) or occlusion of presumed atherosclerotic origin will be randomized to either immediate CAS during EVT or to EVT followed by a deferred strategy, which may include carotid endarterectomy (CEA), CAS, or medical management. CASES will be conducted in 27 EVT centers in Belgium and the Netherlands. A total of 600 patients will be included.STUDY OUTCOMES: The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes include excellent (mRS 0-1) and good (mRS 0-2) functional outcome at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 h and 5-7 days, recanalization, infarct volume at 24 h, ischemic stroke recurrence, carotid artery re-occlusion, symptomatic intracranial hemorrhage, and mortality.SUMMARY: This study will provide high-quality randomized data on the efficacy and safety of immediate CAS in patients undergoing EVT for acute ischemic stroke due to a tandem lesion.TRIAL REGISTRATION: ClinicalTrials.gov NCT06511089; ISRCTN 14956654.",

author = "Louise Maes and {Van Elk}, Theodora and {van der Meij}, Anne and Femke Roelofs and Kris Bogaerts and Bokkers, {Reinoud PH} and {de Borst}, {Gert J} and {den Hertog}, {Heleen M} and Dippel, {Diederik Wj} and Olivier Fran{\c c}ois and No{\'e}mie Ligot and Lingsma, {Hester F} and Majoie, {Charles Blm} and Peluso, {Jo Pp} and Illario Tancredi and {van den Wijngaard}, {Ido R} and {van der Lugt}, Aad and Laetitia Yperzeele and Zeebregts, {Clark J} and Nederkoorn, {Paul J} and Robin Lemmens and Maarten Uyttenboogaart",

year = "2025",

month = feb,

day = "16",

doi = "10.1177/23969873251319941",

language = "English",

journal = "European Stroke Journal",

issn = "2396-9873",

publisher = "SAGE Publishing",

}

Maes, L, Van Elk, T, van der Meij, A, Roelofs, F, Bogaerts, K, Bokkers, RPH, de Borst, GJ, den Hertog, HM, Dippel, DW, François, O, Ligot, N, Lingsma, HF, Majoie, CB, Peluso, JP, Tancredi, I, van den Wijngaard, IR, van der Lugt, A, Yperzeele, L, Zeebregts, CJ, Nederkoorn, PJ, Lemmens, R & Uyttenboogaart, M 2025, 'Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial', European Stroke Journal. https://doi.org/10.1177/23969873251319941

TY - JOUR

T1 - Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial

AU - Maes, Louise

AU - Van Elk, Theodora

AU - van der Meij, Anne

AU - Roelofs, Femke

AU - Bogaerts, Kris

AU - Bokkers, Reinoud PH

AU - de Borst, Gert J

AU - den Hertog, Heleen M

AU - Dippel, Diederik Wj

AU - François, Olivier

AU - Ligot, Noémie

AU - Lingsma, Hester F

AU - Majoie, Charles Blm

AU - Peluso, Jo Pp

AU - Tancredi, Illario

AU - van den Wijngaard, Ido R

AU - van der Lugt, Aad

AU - Yperzeele, Laetitia

AU - Zeebregts, Clark J

AU - Nederkoorn, Paul J

AU - Lemmens, Robin

AU - Uyttenboogaart, Maarten

PY - 2025/2/16

Y1 - 2025/2/16

N2 - BACKGROUND: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.STUDY DESIGN: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial. Patients with a computed tomography angiography proven intracranial LVO in the anterior circulation and ipsilateral proximal carotid artery stenosis (⩾50%) or occlusion of presumed atherosclerotic origin will be randomized to either immediate CAS during EVT or to EVT followed by a deferred strategy, which may include carotid endarterectomy (CEA), CAS, or medical management. CASES will be conducted in 27 EVT centers in Belgium and the Netherlands. A total of 600 patients will be included.STUDY OUTCOMES: The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes include excellent (mRS 0-1) and good (mRS 0-2) functional outcome at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 h and 5-7 days, recanalization, infarct volume at 24 h, ischemic stroke recurrence, carotid artery re-occlusion, symptomatic intracranial hemorrhage, and mortality.SUMMARY: This study will provide high-quality randomized data on the efficacy and safety of immediate CAS in patients undergoing EVT for acute ischemic stroke due to a tandem lesion.TRIAL REGISTRATION: ClinicalTrials.gov NCT06511089; ISRCTN 14956654.

AB - BACKGROUND: The optimal acute management of patients with acute ischemic stroke and a tandem lesion, defined as intracranial large vessel occlusion (LVO) with concomitant carotid artery stenosis or occlusion, remains unclear. Our aim is to assess the efficacy and safety of immediate carotid artery stenting (CAS) compared to delayed management in patients undergoing endovascular treatment (EVT) for acute ischemic stroke due to tandem lesions.STUDY DESIGN: CASES is a phase 3 multicenter prospective randomized open-label blinded endpoint (PROBE) non-inferiority clinical trial. Patients with a computed tomography angiography proven intracranial LVO in the anterior circulation and ipsilateral proximal carotid artery stenosis (⩾50%) or occlusion of presumed atherosclerotic origin will be randomized to either immediate CAS during EVT or to EVT followed by a deferred strategy, which may include carotid endarterectomy (CEA), CAS, or medical management. CASES will be conducted in 27 EVT centers in Belgium and the Netherlands. A total of 600 patients will be included.STUDY OUTCOMES: The primary outcome is the score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes include excellent (mRS 0-1) and good (mRS 0-2) functional outcome at 90 days, stroke severity measured with the National Institutes of Health Stroke Scale (NIHSS) at 24 h and 5-7 days, recanalization, infarct volume at 24 h, ischemic stroke recurrence, carotid artery re-occlusion, symptomatic intracranial hemorrhage, and mortality.SUMMARY: This study will provide high-quality randomized data on the efficacy and safety of immediate CAS in patients undergoing EVT for acute ischemic stroke due to a tandem lesion.TRIAL REGISTRATION: ClinicalTrials.gov NCT06511089; ISRCTN 14956654.

U2 - 10.1177/23969873251319941

DO - 10.1177/23969873251319941

M3 - Article

C2 - 39957001

SN - 2396-9873

JO - European Stroke Journal

JF - European Stroke Journal

ER -

Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES) study protocol for a multicenter randomized clinical trial

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