Comparing stenting and conventional treatment for stroke patients with blocked arteries
IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting - a Pragmatic, International, Multicentre, Randomized Trial
This study is testing if early stenting can help stroke patients with blocked arteries feel better compared to standard treatments when their initial therapy hasn't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 498 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT06472336 on ClinicalTrials.gov |
What this trial studies
This international, multi-center clinical trial aims to compare two treatment options for stroke patients with large vessel occlusion who have not responded to initial endovascular treatment. The study will evaluate the effectiveness and safety of early intracranial stenting against continued conventional endovascular therapy, such as stent-retriever or aspiration methods. By focusing on patients with intracranial atherosclerosis, the trial seeks to provide high-quality evidence on whether stenting can improve outcomes for those who experience recanalization failure. The results could clarify the role of stenting in treating this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with significant stroke symptoms and specific occlusions who have not responded to initial endovascular treatment.
Not a fit: Patients with large infarct cores or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for stroke patients with large vessel occlusions caused by intracranial atherosclerosis.
How similar studies have performed: While intracranial stenting has shown promise in other conditions, this specific approach for stroke treatment is still being evaluated and is not yet widely established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * High probability of underlying intracranial atherosclerotic disease based on the assessment of the treating physician * Age ≥ 18 years * Occluded artery amendable to stenting by judgement of the treating physician * Absence of a large infarct core defined as (posterior circulation) Alberta Stroke Program Early CT Score of 6 or above * Informed Consent as documented by signature or fulfilling the criteria for emergency consent procedures Exclusion Criteria: * 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 * In-hospital Stroke * Known contraindications for anti-platelet therapy * Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys * Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad) * Evidence of an ongoing pregnancy prior to randomization * Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma) * Radiological confirmed evidence of cerebral vasculitis * Evidence of vessel recanalization prior to randomisation * Participation in another interventional trial which could confound the primary endpoint
Where this trial is running
Basel, Canton of Basel-City
- University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marios-Nikos Psychogios, Prof. Dr. — University Hospital, Basel, Switzerland
- Study coordinator: Alex Brehm, PhD
- Email: alex.brehm@usb.ch
- Phone: +41 76 233 74 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.