RecruitingACTRN12622000880741

Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on Outcome (SICARIO-VLC)

Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on disability Outcomes: SICARIO single arm trial on thrombectomy vs historical control.


Sponsor

The University of Newcastle

Enrollment

150 participants

Start Date

Nov 29, 2022

Study Type

Interventional

Conditions

Summary

SICARIO-VLC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume above 100mL. Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-4 (no catastrophic outcome) at 3 months.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

SICARIO-VLC is a clinical trial for people who have had a large ischaemic stroke — where a blood clot blocks an artery and causes a significant area of brain tissue to be at risk. When the affected area of the brain is very large (over 100 mL), doctors have traditionally been reluctant to attempt clot removal (thrombectomy), fearing the risks might outweigh the benefits. This trial challenges that assumption. Participants are randomly assigned to receive either standard medical care or endovascular thrombectomy — a procedure where a catheter is guided through a blood vessel to physically remove the clot from the brain. The primary question is whether thrombectomy prevents the worst outcomes (such as death or severe disability) in patients with very large stroke cores. You may be eligible if you are 18 or older, have had a large vessel occlusion stroke within the last 24 hours, have a very large ischaemic core on imaging (over 100 mL), and were previously functioning well (minimal disability). People with brain bleeding, severe pre-existing disability, vertebral or basilar artery occlusions, or a terminal illness are not eligible. Time is critical — the procedure must be started within two hours of brain imaging.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

SICARIO-VLC will include patients presenting with a baseline perfusion core lesion >100mL and will be allocated to receive thrombectomy. The device used will be at the proceduralist’s discretion.

SICARIO-VLC will include patients presenting with a baseline perfusion core lesion >100mL and will be allocated to receive thrombectomy. The device used will be at the proceduralist’s discretion. The thrombolysis decision will be up to the treating physicians’ decision. This will minimize the chances of selection bias as the research team members are not interfering in the clinician’s judgment. Two types of standard of care clot retrieval devices used. (brands may vary between countries) 1. Stent retrievers such as Trevo by Stryker, Solitaire by Medtronic. 2. Aspiration catheters such as Penumbra Duration of thrombectomy procedure depends on complexity, approximately 1-2 hours. Procedure to be initiated within 2 hours of presentation as per protocol, performed by the neurointerventionalist.


Locations(14)

John Hunter Hospital - New Lambton

NSW,SA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,SA,VIC, Australia

Prince of Wales Hospital - Randwick

NSW,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,SA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,SA,VIC, Australia

Box Hill Hospital - Box Hill

NSW,SA,VIC, Australia

Sunshine Hospital - St Albans

NSW,SA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,SA,VIC, Australia

Catalunya / Barcelona, Spain

Christchurch, New Zealand

Christchurch, New Zealand

Christchurch, New Zealand

Christchurch, New Zealand

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ACTRN12622000880741