IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting - a Pragmatic, International, Multicentre, Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patients presenting within 24 hours of last seen well to the treating hospital

• 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

Locations
Other Locations
Switzerland
University Hospital Basel, Department of Interventional and Diagnostical Neuroradiology
RECRUITING
Basel
Contact Information
Primary
Alex Brehm, PhD
alex.brehm@usb.ch
+41 76 233 74 90
Backup
Marios-Nikos Psychogios, Prof. Dr.
marios.psychogios@usb.ch
+41 61 328 59 36
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2027-08
Participants
Target number of participants: 498
Treatments
Experimental: Intervention group
In patients within the intervention group, the treating physician attempts to perform intracranial stenting (with or without balloon dilation).
Active_comparator: Control group
In patients within the control group, the treating physician does not perform intracranial stenting and/or balloon dilation. Conventional endovascular therapy will be continued.
Related Therapeutic Areas
Sponsors
Collaborators: Acandis GmbH, Swiss National Science Foundation
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov

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