IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)
NCT Number: NCT06472336
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke|Stroke, Acute Ischemic|Intracranial Atherosclerosis
Interventions: PROCEDURE: Intracranial stenting|PROCEDURE: Continuation of conventional endovascular therapy (EVT)
Sponsor: University Hospital, Basel, Switzerland
Collaborators: Swiss National Science Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 498
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-08
Locations: University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology, Basel, BS, 4031, Switzerland

Summary:
The goal of this international, multi-center, randomized clinical trial is to compare two treatment options, early intracranial stenting and continued stent-retriever or aspiration based endovascular treatment, for stroke patients with a large vessel occlusion, who experienced failure of recanalisation after initial treatment due to intracranial atherosclerosis.

Primary Outcome Measures: Assessment whether intracranial stenting compared to conventional endovascular treatment is beneficial regarding patient's functional status, To evaluate whether intracranial stenting compared to conventional endovascular treatment is beneficial, the degree of disability and dependency in everyday life is measured with the modified Rankin Scale (mRS), which is a standard tool to assess the neurological outcome in trials with acute severe brain disease. The mRS ranges from 0 (no disability) to 6 (death). Lower values indicate less disability.

The assessment of mRS is performed by an independent and blinded person that is certified for scoring the mRS., 90 days post randomization
Secondary Outcome Measures: Change in the National Institutes of Health Stroke Scale (NIHSS) score, To compare the impact of the two treatment options on the neurological deficit of the patient, the change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline and post randomization is evaluated. The NIHSS is a standard tool to assess the severity of stroke symptoms.

The NIHSS ranges from 0 to 42 with less values indicating less neurological deficit., Baseline, 24 hours, 5-7 days and, optionally, 90 days post randomization|Assessment of the discharge location, The discharge location is assessed at the follow-up visit 90 days after randomization. Discharge location could either be: (a) other hospital, (b) rehabilitation facility, (c) nursing home, (d) residential home or (e) own household., 90 days post randomization|Assessment of the cognitive function, To assess the cognitive function, the validated Montreal Cognitive Assessment (MoCA) is used at the follow-up visit 90 days after randomization. If the patient cannot perform the test or is deceased, his/her score is rated as minimal.

Scores range from 0 to 30 with higher scores indicating better cognitive function. A score of 26 or above indicates normal cognitive function., 90 days post randomization|Assessment of the quality of life, To assess the quality of life, the standardized questionnaire, EuroQol-5d, is used at 90 and 365 days after randomization. At 365 days the assessment is conduct as a telephone interview., 90 and 365 days post randomization|Assessment of disability and dependency in everyday live activities, To assess the functional outcome, the modified Rankin Scale (mRS) is measured after 365 days via a telephone interview. The mRS ranges from 0 (no disability) to 6 (death). Lower values indicate less disability., 365 days post randomization|Assessment of the residential status, To assess the patient's residential status, a telephone interview with the patient or if not available his next of kin/caregiver is performed 365 days after the randomization., 365 days post randomization|Symptomatic intracranial haemorrhage (sICH), The incidence of Symptomatic intracranial haemorrhage (sICH) is assessed based on the modified Safe Implementation of Treatments in Stroke-Monitoring Study (SITS-MOST) criteria. The SITS-MOST criteria define sICH as a parenchymal hematoma grade 1 or 2, indicated by an increase of at least 4 points on the National institute of Health Stroke Scale (NIHSS) (compared to the lowest recorded NIHSS post randomization). sICH is the main safety outcome in most stroke trials., 0-24 hours post randomization|Percentage of penumbral tissue saved (imaging based outcome parameter), Percentage of penumbral tissue saved, which is defined as the proportion of tissue at risk at baseline that did not progress to infarction at 24 hours after randomization., 0 - 24 hours post randomization|Grading of reperfusion at the end of the intervention (imaging based outcome parameter), The modified Thrombolysis In Cerebral Infarction (mTICI) score will be used to grade the reperfusion success at the end of the procedure. mTICI ranges from 0 (no reperfusion) to 3 (full reperfusion), 0 - 60 minutes post randomization|Grading of recanalization at 24 hours after the randomization (imaging based outcome parameter), The arterial occlusion lesion scale will be used to grade the vessel status at 24 hours after randomization on a CT-angiography or MR-angiography (if done according to local standards of care). It ranges from 0 to 3 with 0 indicating no recanalization and 3 complete recanalization., 24 hours post randomization
Other Outcome Measures: Serious Adverse Events (SAEs), The SAEs are assessed by a neurologist. The patient is asked if he/she has had any health problems since the last study visit. In addition, the patient's medical record is reviewed. If the patient is unable to come to the clinical visit at 90 days, he/she will be contacted by telephone. If patients/relatives do not respond, the general practitioner or treating physician will be contacted., 24 hours, 7-10 days, and 90 days post randomization|All-cause mortality, To assess the safety of the two treatment options, the mortality is determined., 7-10 days, 90 days, and 365 days post randomization|Reoccurrence of ischemic stroke in the same territory, The assessment of reoccurrence of ischemic stroke in the same territory is based on the clinical evaluation of the patient and imaging findings., 0-90 days post randomization