Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well - SELECT LATE Trial
Amrou Sarraj
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).
Description
SELECT LATE is a prospective, phase III, randomized, international, multicenter, assessor-blinded controlled trial evaluating 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). Patients with the final diagnosis of an acute ischemic stroke due to a large vessel occlusion in the internal carotid artery (I…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: General Inclusion Criteria: * 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…
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.
Locations (6)
- University of ChicagoChicago, Illinois
- The University of Kansas Health SystemKansas City, Kansas
- Washington University School of MedicineSt Louis, Missouri
- Rhode Island HospitalProvidence, Rhode Island
- Baylor University Medical CenterDallas, Texas
- West Virginia UniversityMorgantown, West Virginia