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

NCT07115940 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STUDY20250993G250153
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Acute Ischemic Stroke

Keywords

Endovascular Thrombectomy; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• The distribution of the modified Rankin Scale score

  The modified Rankin Scale (a 7-point scoring system, 0 indicates no residual stroke symptoms and 6 represents death) is assessed through patient/caregiver interview by trained and certified raters. The modified Rankin Scale score is the standard FDA-recognized measure of stroke outcome, used in clinical trials testing acute stroke therapies.

  90 days ± 15 days

Secondary Outcomes (7)

• Utility-weighted modified Rankin Scale scores

  90 days ± 15 days

• Domain-specific scores for NeuroQoL

  90 days ± 15 days

• Functional independence (mRS 0-2)

  90 days ± 15 days

• The distribution of the modified Rankin Scale score

  1 year ± 30 days

• Functional independence (mRS 0-2)

  1 year ± 30 days

Other Outcomes (4)

• Symptomatic Intracerebral Hemorrhage (sICH)

  24 hours ± 6 hours

• Presence and type of Intracerebral Hemorrhage (ICH)

  24 hours ± 6 hours

• Mortality

  90 days ± 5 days

Study Arms (2)

Medical Management with Endovascular Thrombectomy

EXPERIMENTAL

Medical management with endovascular thrombectomy (EVT) - 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. Removing this occlusion results in restoration of blood flow to ischemic brain tissue and salvage of 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.

Device: Endovascular Thrombectomy; Other: Medical Management

Medical Management without Endovascular Thrombectomy

ACTIVE COMPARATOR

Medical management without endovascular thrombectomy 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.

Other: Medical Management

Interventions

Endovascular Thrombectomy DEVICE

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.

Medical Management with Endovascular Thrombectomy

Medical Management OTHER

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.

Medical Management with Endovascular Thrombectomy; Medical Management without Endovascular Thrombectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current participation in another investigational interventional drug or device study.
• Baseline Platelet count \<100,000/μl
• 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.
• 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.

Sponsors & Collaborators

• Amrou Sarraj: lead
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Amrou Sarraj, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Rownd, MED

CONTACT

216-286-6458; Kathryn.Rownd@UHhospitals.org

Deep Pujara, MBBS, MPH, MS

CONTACT

Deep.Pujara@UHHospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology at the CWRU School of Medicine

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share