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

Effects of Thrombectomy in Stroke Patients

K
Kaustubh Limaye, MD

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase N/A
3 participants needed
2 Locations

Brief description of study

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).

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Ischemic Stroke
  • Age: 18 years - 85 years
  • Gender: All

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.

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 with midline shift (>1mm)
  • 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.

This study investigates the effects of adding endovascular thrombectomy to medical management for patients who have had an acute ischemic stroke. An ischemic stroke happens when a blood vessel supplying blood to the brain is obstructed. This study focuses on patients who have a blockage in a large blood vessel in the front part of the brain and present between 24 to 72 hours after the stroke started. The aim is to see if this treatment combination leads to better outcomes in daily activities after 90 days.

Participants will be randomly assigned to receive either the thrombectomy plus medical management or medical management alone. They will undergo several assessments, including brain scans, to check the effects of the treatments. The study will measure the participants' ability to perform daily activities and their quality of life after 90 days. Safety will also be monitored by looking at any serious side effects, such as bleeding in the brain.

  • Who can participate: Adults aged 18 to 85 years who have had an acute ischemic stroke with a large vessel blockage can participate. They must meet specific criteria on a stroke severity scale and be able to consent to the procedures.
  • Study details: Participants will either receive an endovascular thrombectomy, which is a procedure to remove the blood clot, plus medical management, or just medical management. A placebo is not used in this study.
Updated on 30 Apr 2026. Study ID: NEUR-UHCMC-SELECT-LATE, 29325
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only