RecruitingNot ApplicableNCT07115940

Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well

Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well - SELECT LATE Trial

Sponsor

Amrou Sarraj

Enrollment

408 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

Summary

SELECT LATE trial aims to evaluate if addition of endovascular thrombectomy to medical management in patients presenting with acute ischemic stroke and a proximal large vessel occlusion in the anterior circulation between 24 and 72 hours of stroke onset results in achieving better functional outcomes (measured using modified Rankin Scale Scores) at 90-day follow-up (± 15 days).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria11

Adults (18-85\* years) with the final diagnosis of an acute ischemic stroke$
NIHSS ≥ 6
Time from last-known-well to randomization \>24 - 72 hours
Pre-stroke modified Rankin Scale score of 0-1
Eligible for thrombectomy and medical management
Signed Informed Consent obtained
Subject willing to comply with the protocol follow-up requirements
Anticipated life expectancy of at least 3 months \*Inclusive of both 18 and 85 years of age (i.e. up to 86th birthdate). $Subacute presentation - In-hospital stroke admissions with fluctuating clinical symptoms for patients who presented to EVT centers within 24 hours of when they were last known well will not be eligible for the trial.
Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions), as determined by MR Angiography (MRA) or CT Angiography (CTA)
CT ASPECTS 3-10
CT Perfusion ischemic core (rCBF \<30%)# volume ≤150 ml OR MR Diffusion ischemic core (ADC \<620x10-6 mm2/s)# volume ≤150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria.

Exclusion Criteria10

Current participation in another investigational interventional drug or device study.
Baseline Platelet count \<100,000/μl
Evidence of intracranial tumor (except small meningioma \<3cm without signs of edema or inflammation), acute intracranial hemorrhage, or arteriovenous malformation
Significant mass effect, defined as midline shift (\>3mm) using foramen of monroe (anterior margin of third ventricle) as the marker for midline instead of septum pellucidum AND/OR Effacement of sulci in contralateral hemisphere
Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
Any signs of established infarct, demarcating hypodensity and area of cerebral edema on non-contrast CT
CT ASPECTS 0-2
CT Perfusion ischemic core (rCBF \<30%)# volume \>150 ml OR MR Diffusion ischemic core (ADC \<620x10-6 mm2/s)# volume \>150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria.

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Interventions

DEVICEEndovascular Thrombectomy

EVT will be provided in addition to medical management and is a procedure to remove a thrombus in one of the brain arteries that is obstructing the blood flow and is responsible for the occurrence of stroke. Removing this occlusion results in restoration of blood flow to ischemic brain tissue and salvages the parts that are still viable, which is expected to improve functional outcomes. Endovascular thrombectomy procedure will be performed using stent retrievers, aspiration devices or combination approach at the discretion of the treating physician, using devices approved by the local regulatory authority. For patients treated in the United States of America, only US Food and Drug Administration-approved neurothrombectomy devices can be used.

OTHERMedical Management

Medical management comprises various measures to prevent further deterioration, enhance patients' outcomes and prevent occurrence of a secondary stroke in short and long term. This includes 1) evidence-based practices for blood pressure management 2) Neurocritical care monitoring with appropriate osmotic therapy and neurosurgical interventions such as hemicraniectomy for management of cerebral edema that occurs due to infracted brain tissue based on local institutional protocol, 3) stroke etiology identification by requisite neurology , cardiology, immunology evaluations and 4) short and long-term strategies for secondary stroke prevention, including anticoagulation, antiplatelet therapy, medical optimization and modification of stroke risk factors such as hypertension, hyperlipidemia, diabetes and other potential comorbidities.