IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A relevant clinical deficit defined as a National Institute of Health Stoke Scale (NIHSS) Score of ≥ 6 points for anterior circulation stroke and a NIHSS Score of ≥ 10 for posterior circulation stroke
Anticipated randomization within 24 hours of last seen well (LSW)
Occlusion of the Internal Carotid Artery, the M1 segment, the proximal/dominant M2 segment of the Middle Cerebral Artery, the Basilar Artery or the V4 segment of the Vertebral Artery
Absence of recanalization (thrombolysis in myocardial infarction score of 0 or 1) after up to three endovascular treatment passes
Disqualifiers
Acute intracranial haemorrhage
Pre-stroke modified Rankin Scale score of 3 or above
Known, severe comorbidities, which will likely prevent improvement or follow-up (cancer, alcohol/drug abuse or dementia)
Known clotting disease or suspicion of underlying disease which might lead to a hyper coagulant state
Trial design
Design model
Parallel
Treatments tested in this trial
Intracranial stenting
Procedure/SurgeryIntracranial stenting (+/- balloon dilatation) will be performed. Decisions regarding intracranial stenting are solely made by the treating physician. This means in specific, that the treating physician decides based on his/her judgement or based on local standards (as reported in the literature) on the devices and/or concomitant medications (including infusion/administration of antiplatelet medicine) used for intracranial stenting.
Continuation of conventional endovascular therapy (EVT)
Procedure/SurgeryPatients undergo either (a) continued stent retriever or contact aspiration based endovascular treatment manoeuvres, (b) infusion/administration of antiplatelet medication or (c) stop of the procedure depending on local standard treatment approaches.
Treatment groups
498 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
90 days post randomizationSecondary outcomes
1
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.
Time frame
Baseline, 24 hours, 5-7 days and, optionally, 90 days post randomization2
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.
Time frame
90 days post randomization3
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.
Time frame
90 days post randomization4
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.
Time frame
90 and 365 days post randomizationOther outcomes
1
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.
Time frame
24 hours, 7-10 days, and 90 days post randomization2
All-cause mortality
To assess the safety of the two treatment options, the mortality is determined.
Time frame
7-10 days, 90 days, and 365 days post randomization3
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.
Time frame
0-90 days post randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Swiss National Science Foundation
Collaborator
Acandis GmbH
Collaborator
Phenox GmbH
Collaborator
Source ClinicalTrials.gov