Intracranial stenting in case of treatment failure for LVO stroke
Research type
Research Study
Full title
IntraCranial Atherosclerosis Related large-vessel occlusion treated with Urgent Stenting - a pragmatic, international, multicentre, randomized trial (ICARUS)
IRAS ID
346768
Contact name
Thomas Booth
Contact email
Sponsor organisation
University Hospital Basel
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
Background
Acute ischemic stroke (AIS) due to a large vessel occlusion (LVO) is a devastating disease. In this disease a clot is blocking an artery, leading to the death of brain cells. Mechanical extraction of the clot has become the standard treatment for LVO patients.
It has improved their chances of continuing an independent self-sufficient live dramatically. However, in approximately 10-20% this treatment approach is not successful. The most common reason for treatment failure is underlying intracranial atherosclerotic disease (ICAD). Failure to extract the clot is associated with markedly worse outcomes with rates of severe disability and death exceeding 70%. A possible solution in this scenario is the use of intracranial stenting. While retrospective data suggests a strong positive effect on long-term clinical outcomes, randomized-controlled data on the effects of early intracranial stenting is missing.
Aim
To address this uncertainty, we aim to evaluate the potential long-term benefits of intracranial stenting in patients with an LVO in which the current standard approach of extracting the clot is not successful.
Methodology
ICARUS will be performed as a pragmatic, multicentre, randomized-controlled trial with blinded endpoint assessment. The largest patient interest group for stroke patients in Switzerland acknowledges the relevance of our chosen primary outcome, which will be disability or dependence in daily activities 90 days after stroke. We plan to recruit up to 498 patients in up to 50 high volume stroke centres over the enrolment period of 36 months.
Potential significance
If the proposed trial proofs the benefit of early intracranial stenting in this patient group, it is likely that it will influence future decisions regarding standard of care. It would have a substantial impact on the handicap and quality of life of a large group of ischemic stroke patients.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0074
Date of REC Opinion
20 Mar 2025
REC opinion
Favourable Opinion