Thrombectomy plus medical care versus medical care alone for large-vessel ischemic stroke 24–72 hours after last known well

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

This will see if adding endovascular thrombectomy to usual medical care helps adults with a large-vessel ischemic stroke who arrive 24–72 hours after they were last known to be well.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 408 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Hospitals Cleveland Medical Center (Academic / other)
• Locations: 6 sites (Chicago, Illinois and 5 other locations)
• Trial ID: NCT07115940 on ClinicalTrials.gov

What this trial studies

SELECT LATE randomly assigns eligible adults with an anterior-circulation large-vessel occlusion who present 24–72 hours after last known well to receive endovascular thrombectomy plus standard medical care or standard medical care alone, with treating centers and outcome assessors blinded to assignment when possible. Key imaging eligibility includes non-contrast CT ASPECTS 3–10 and an ischemic core volume ≤150 mL, and patients must have NIHSS ≥6 and pre-stroke mRS 0–1. The primary outcome is a shift in modified Rankin Scale scores at 90 days (±15 days); secondary outcomes include functional independence, utility-weighted mRS, quality of life measures, and safety endpoints such as mortality and severe disability. Assessments occur at baseline, 24 hours, discharge, 90 days, and one year.

Who should consider this trial

Good fit: Adults aged 18–85 with an acute ischemic stroke due to an ICA or MCA-M1 large-vessel occlusion who present 24–72 hours after last known well, have NIHSS ≥6, pre-stroke mRS 0–1, and meet imaging criteria (ASPECTS 3–10 and ischemic core ≤150 mL) are the ideal candidates.

Not a fit: Patients with very large ischemic cores (>150 mL), posterior-circulation occlusions, significant pre-stroke disability (mRS >1), presentation outside the 24–72 hour window, or other exclusion criteria (for example platelet count <100,000/μL or concurrent participation in another interventional study) are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, adding thrombectomy in this later time window could increase the chances of better functional recovery and independence at 90 days for patients with late-presenting large-vessel occlusions.

How similar studies have performed: Previous randomized trials (DAWN and DEFUSE 3) demonstrated benefit for thrombectomy out to 24 hours, but randomized evidence for the 24–72 hour window is limited, so this approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois and 5 other locations

• University of Chicago — Chicago, Illinois, United States (Recruiting)
• The University of Kansas Health System — Kansas City, Kansas, United States (Recruiting)
• Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
• Rhode Island Hospital — Providence, Rhode Island, United States (Recruiting)
• Baylor University Medical Center — Dallas, Texas, United States (Recruiting)
• West Virginia University — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Amrou Sarraj, MD — University Hospitals
• Study coordinator: Kate Rownd, MED

Conditions Acute Ischemic Stroke; Endovascular Thrombectomy; Mechanical Thrombectomy