Carotid Artery Stenting During Endovascular Treatment of Acute Stroke
NCT Number: NCT06511089
Acronym: CASES
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Stroke, Acute|Stroke, Ischemic|Carotid Stenosis|Carotid Atherosclerosis|Carotid Occlusion
Interventions: PROCEDURE: carotid artery stenting during EVT|OTHER: no carotid artery stenting during EVT
Sponsor: University Medical Center Groningen
Collaborators: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-11-15
Completion Date: 2026-11-15
Locations: University Medical Center Groningen, Groningen, 9713 GZ, Netherlands

Summary:
Rationale: Approximately 20% of the patients with acute ischemic stroke due to an intracranial large vessel occlusion (LVO) has a high-grade stenosis in the ipsilateral cervical carotid artery. It is uncertain whether immediate carotid artery stenting (CAS) of a cervical carotid artery stenosis during endovascular thrombectomy (EVT) is beneficial. Immediate CAS could improve cerebral perfusion and prevent recurrent ischemic stroke but could also increase the chance of intracranial hemorrhagic complications due to hyperperfusion syndrome or to the required antiplatelet treatment to prevent stent occlusion. Moreover, some patients end up with a severe disabling stroke after EVT. In these patients carotid revascularization by carotid endarterectomy (CEA) or CAS would usually not be performed but these patients would be treated by medical management only.

Objective: to assess the safety and efficacy of immediate cervical CAS during EVT in patients with acute ischemic stroke due to LVO with a high-grade stenosis \>50% or occlusion of the ipsilateral cervical carotid artery.

Study design: prospective randomized open label controlled trial comparing immediate CAS during EVT versus EVT with deferred treatment of the cervical carotid artery lesion (deferred CAS/CEA or medical management alone). Outcome assessment will be blinded for treatment allocation.

Primary Outcome Measures: Modified Rankin Scale score, Stroke-related disability measured using the Modified Rankin Scale (mRS) Score at 90 days after stroke onset., 90 days
Secondary Outcome Measures: NIHSS score 24 hours, Stroke severity, 24 hours|TICI score, Recanalization after EVT, during EVT|Final infarct volume on brain CT scan at 24 hours, Final infarct volume on brain CT scan at 24 hours, 24 hours|Arterial occlusive lesion score at 24 hours, Arterial occlusive lesion score at 24 hours, 24 hours|Any stroke, Any ischemic, hemorrhagic stroke or TIA, 90 days|Recurrent ipsilateral TIA/ischemic stroke, Recurrent ipsilateral TIA/ischemic stroke, 90 days|Carotid re-occlusion, Carotid re-occlusion on CTA at 24 hours or duplex at 90 days, 24 hours and 90 days|Mortality, Mortality, 90 days|Quality of Life, Quality of life measured with the EQ5D-5L), 90 days
Other Outcome Measures: Symptomatic Intracranial hemorrhage, Symptomatic Intracranial hemorrhage, 24 hours and 90 days|Any intracranial hemorrhage, Any intracranial hemorrhage, 24 hours and 90 days