Recruiting

Endovascular Thrombectomy

Sponsor:

Amrou Sarraj

Code:

NCT07115940

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endovascular Thrombectomy

Medical Management

Study Details

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

Study ID

NCT07115940

Start date

Apr 13, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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/μl

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 ≤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.

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.

Study Design

Enrollment

408 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medical Management with Endovascular Thrombectomy

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.

active comparator: Medical Management without Endovascular Thrombectomy

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.

Interventions

Endovascular 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.

Medical 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.

Primary outcome measure

  • The distribution of the modified Rankin Scale score [ Time Frame: 90 days ± 15 days ]

Central Contacts and Locations

Central contacts

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Tareq Kass-Hout, MD

The University of Kansas Health System

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Principal Investigator:

Michael G Abraham, MD, FAHA, FSVIN

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 61611

Contacts

Alyssa Hiserote, MSN, RN

314-369-6880calyssa@wustl.edu

Jennifer Babka, PhD, RN

314-369-6880babkaj@wustl.edu

Principal Investigator:

Brendan Eby, MD

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Wendy Smith, BS, RTRCV, CCRP

401-444-4233wsmith@brownhealth.org

Principal Investigator:

Dylan Wolman, MD

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Osman Mir, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Sohyun Boo, MD

More Information

Sponsor

Amrou Sarraj

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Endovascular Thrombectomy
  • Mechanical Thrombectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amrou Sarraj on 2026-07-06.