Comparing stenting and conventional treatment for stroke patients with blocked arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.