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

RecruitingNAAges 18 Years - 85 YearsAllAmrou Sarraj
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In plain words

What the trial is, and whether it could suit you

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 (ยฑ 15 days).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: General Inclusion Criteria: * Adults (18-85\* years) with the final diagnosis of an acute ischemic stroke$ * NIHSS โ‰ฅ 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. General Exclusion Criteria * Current participation in another investigational interventional drug or device study. * Baseline Platelet count \<100,000/ฮผl Imaging Inclusion Criteria * 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 โ‰ค150 ml OR MR Diffusion ischemic core (ADC \<620x10-6 mm2/s)# volume โ‰ค150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to assess ischemic core criteria. Imaging Exclusion Criteria * 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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What it tests

  • Endovascular Thrombectomy
  • Medical Management
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Where

6 sites
University of Chicago
Chicago, United States
The University of Kansas Health System
Kansas City, United States
Washington University School of Medicine
St Louis, United States
Rhode Island Hospital
Providence, United States
Baylor University Medical Center
Dallas, United States
West Virginia University
Morgantown, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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