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Acute Ischemic StrokeSELECT LATENCT07115940

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

A study testing Endovascular Thrombectomy and Medical Management in people with Acute Ischemic Stroke, run by Amrou Sarraj at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Endovascular Thrombectomy and Medical Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
6 sitesUnited States
Study dates
13 Apr 2026to 1 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Deep Pujara, MBBS, MPH, MS contact

Deep.Pujara@UHHospitals.org

6 sites in 1 country

United States6 sites, 6 recruiting
  • University of Chicago

    Chicago, Illinois, 60637

    Khalid Trad, MD, 708-886-0785, khalid.trad@bsd.uchicago.edu

    Erin King, PhD, OTR/L, erinking1@bsd.uchicago.edu

    Recruiting
  • Baylor University Medical Center

    Dallas, Texas, 75246

    Mariana Hurutado-Rodriguez, 214-346-1330, Mariana.Hurutado@BSWHealth.org

    Daniela Gonzalez, 214-820-6243, Daniela.gonzalez1@bswhealth.org

    Recruiting
  • The University of Kansas Health System

    Kansas City, Kansas, 66103

    Anika Zainab, 913-574-4186, azainab@kumc.edu

    Margaret Houghton, mhoughton3@kumc.edu

    Recruiting
  • West Virginia University

    Morgantown, West Virginia, 26506

    Jennifer Domico, RN, CCRP, 304-293-7012 ext. 37012, Jennifer.domico@WVUmedicine.org

    Mohammed Elshahat, MD, 304-293-1443 ext. 31443, mohammed.elshahat@hsc.wvu.edu

    Recruiting
  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Wendy Smith, BS, RTRCV, CCRP, 401-444-4233, wsmith@brownhealth.org

    Barbara Marcotte, RTRCT, 401-444-8055, mbarcotte@brownhealth.org

    Recruiting
  • Washington University School of Medicine

    St Louis, Missouri, 61611

    Alyssa Hiserote, MSN, RN, 314-369-6880, calyssa@wustl.edu

    Jennifer Babka, PhD, RN, 314-369-6880, babkaj@wustl.edu

    Recruiting

Other trials in United States

About this study

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

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).

Read the detailed 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 (ICA) or M1 segment of the middle cerebral artery (MCA), who present between 24-72 hours of when they were last known to be well and meet neuroimaging eligibility criteria [Non-contrast CT ASPECTS 3-10 and Ischemic core volume ≤150ml] will be randomized in a 1:1 ratio to thrombectomy plus medical management vs medical management alone. Patient assessments will be made at baseline, 24 hours post-randomization, discharge, 90 days and 1 year.

The primary endpoint is the Modified Rankin Scale (mRS) score at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS scores, with scores of 5 (severe disability requiring constant care) and 6 (death) merged to avoid considering a shift from 6 to 5 as an improvement. Secondary outcomes include functional independence (mRS score of 0-2), Utility weighted mRS, and Quality of Life measures. Safety outcomes include mortality, severe disability or death (mRS 5-6), incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST); and Imaging outcomes include infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI is not feasible) 24-72 hours after randomization.

A maximum of 408 patients will be randomized across the study sites. Online randomization with Common Scale-Minimum Sufficient Balance algorithm will be used to balance the distribution of important variables. Interim analyses will be conducted at 136 and 272 patients, at which time the study may stop for efficacy or futility.

Being tested
Endovascular Thrombectomy, Medical Management
Keywords
Endovascular Thrombectomy, Mechanical Thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular ThrombectomyDevice

    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 ManagementOther

    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.

Study groups in NCT07115940
Study groupRoleWhat they receive
Medical Management with Endovascular ThrombectomyExperimentalMedical 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.
Receives: Device: Endovascular Thrombectomy; Other: Medical Management
Medical Management without Endovascular ThrombectomyActive comparatorMedical 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.
Receives: Other: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days ± 15 days

Secondary outcomes (7)
  1. Utility-weighted modified Rankin Scale scores

    The Utility-Weighted Modified Rankin Scale (UW-mRS) is an advancement in the assessment of disability and functional independence for patients with neurological conditions. By incorporating patient preferences, it complements the traditional Modified Rankin Scale (mRS) by capturing individual preferences for specific health states. UW mRS is calculated by incorporating responses from the EuroQol-5 Dimension (EQ-5D) questionnaire, with a maximum score of 10 and minimum score of 0 and higher score indicating better functional status.

    Measured: 90 days ± 15 days

  2. Domain-specific scores for NeuroQoL

    The Neuro-Quality of Life (Neuro-QoL) measurement system evaluates health-related quality of life (HRQoL) in patients with neurological conditions through patient-reported outcomes, incorporating the impact of diseases and treatments on patients' daily lives and well-being. Neuro-QoL comprises item banks in Motor, Social, Cognitive and Depression modules. Responses to questions are converted into T-scores ranging from 0 to 100, with higher scores for Motor, Social and Cognitive domains indicating better quality of life and higher scores for depression domain indicating worse quality of life.

    Measured: 90 days ± 15 days

  3. Functional independence (mRS 0-2)

    Functional independence is identified by pooling all patients achieving a) no stroke deficits (mRS of 0), b) minimal stroke deficits without any functional limitations (mRS of 1) and c) functional limitations that do not interfere with independent living (mRS of 2) and illustrates being able to execute all day to day activities required for independent living, including bathing and dressing, cooking, grocery shopping and handling finances, with or without some degree of stroke deficits present.

    Measured: 90 days ± 15 days

  4. 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.

    Measured: 1 year ± 30 days

  5. Functional independence (mRS 0-2)

    Functional independence is identified by pooling all patients achieving a) no stroke deficits (mRS of 0), b) minimal stroke deficits without any functional limitations (mRS of 1) and c) functional limitations that do not interfere with independent living (mRS of 2) and illustrates being able to execute all day to day activities required for independent living, including bathing and dressing, cooking, grocery shopping and handling finances, with or without some degree of stroke deficits present.

    Measured: 1 year ± 30 days

  6. Utility-weighted modified Rankin Scale scores

    The Utility-Weighted Modified Rankin Scale (UW-mRS) is an advancement in the assessment of disability and functional independence for patients with neurological conditions. By incorporating patient preferences, it complements the traditional Modified Rankin Scale (mRS) by capturing individual preferences for specific health states. UW mRS is calculated by incorporating responses from the EuroQol-5 Dimension (EQ-5D) questionnaire, with a maximum score of 10 and minimum score of 0 and higher score indicating better functional status.

    Measured: 1 year ± 30 days

  7. Domain-specific scores for NeuroQoL

    The Neuro-Quality of Life (Neuro-QoL) measurement system evaluates health-related quality of life (HRQoL) in patients with neurological conditions through patient-reported outcomes, incorporating the impact of diseases and treatments on patients' daily lives and well-being. Neuro-QoL comprises item banks in Motor, Social, Cognitive and Depression modules. Responses to questions are converted into T-scores ranging from 0 to 100, with higher scores for Motor, Social and Cognitive domains indicating better quality of life and higher scores for depression domain indicating worse quality of life.

    Measured: 1 year ± 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start13 Apr 2026
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
408 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07115940
Sponsor's protocol ID
STUDY20250993
Other IDs
G250153
Acronym
SELECT LATE
Status last verified
Jul 2026
First submitted
4 Aug 2025
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified Individual patient-level data will be submitted to repository designated by the funding agency.

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular Thrombectomy and Medical Management in people with Acute Ischemic Stroke, run by Amrou Sarraj at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kate Rownd, MED (216-286-6458, Kathryn.Rownd@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The distribution of the modified Rankin Scale score (time frame: 90 days ± 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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