A Randomized Trial of Imaging Selection Modalities for Stroke Thrombectomy (NO-SELECT)

Study Overview
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Brief Summary
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Several studies suggest that advanced multi-modal imaging with CTP should be used to screen late time window stroke patients for thrombectomy. However, NCCT is more accessible when comparing with CTP. It is unclear whether the NCCT-based ASPECTS can be used as an imaging criterion to screen patients for thrombectomy. The newly published MR CLEAN-LATE and TENSION trials used NCCT or CTA, but still relied on ASPECTS scores to evaluate and select patients for endovascular therapy. However, different trials have different time windows. The aim of this trial was to assess the clinical outcomes of stroke patients with anterior large vessel occlusion who selected by simple imaging (NCCT) comparing via standard imaging screening strategy (CTP/MRI). The hypothesis is that simple imaging is non-inferior to standard imaging selection strategy in terms of achieving favorable outcomes.

Official Title
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Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Cluster-randomized, Crossover Trial

Conditions
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Stroke, Ischemic, Stroke, Acute

Intervention / Treatment
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* Other: Simplified imaging strategy
* Other: Standard imaging strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Presenting with acute ischemic stroke within 24 hours from last known well to randomization Baseline NIHSS score >6 points Planned treatment with endovascular treatment by clinical care team Informed consent obtained from patients or their legal representatives CT or MR excludes hemorrhage Occlusion of the intracranial internal carotid artery, the first or second segment of the middle cerebral artery (MCA-M1 or -M2), or vertebrobasilar artery confirmed by CTA/MRA/DSA Exclusion Criteria: Allergy to radiographic contrast agents, or nitinol devices; Currently pregnant or lactating (women patients); Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation); Brain tumors with mass effect (except meningiomas) that are radiographically pleasant; Intracranial aneurysm, arteriovenous malformation; Any terminal illness with life expectancy less than 6 months; Unlikely to be available for 90-day follow-up.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple imaging<br>NCCT and CTA will be used to screen patients for endovascular treatment | Other: Simplified imaging strategy<br>* NCCT and CTA will be used to screen patients for endovascular treatment<br>|
| Active Comparator: Standard imaging<br>NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment | Other: Standard imaging strategy<br>* NCCT-ASPECTS (pc-ASPECTS), CTA, and CTP will be used to screen patients for endovascular treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| favorable outcome at 90 days | defined as modified Rankin scale score of 0 to 3. Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death. | 90 days post-endovascular treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic intracranial hemorrhage within 48 hours | symptomatic intracranial hemorrhage according to Heidelberg criteria | within 48 hours post-endovascular treatment | 
| mortality at 90 days | defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period | 90 days post-endovascular treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovascular treatment, large vessel occlusion, acute ischemic stroke, computed tomography perfusion, non-contrast computed tomography, Alberta Stroke Program Early CT score