No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
408 (estimated)
Sponsor
Amrou Sarraj · Other
Who this trial is looking for
This trial is looking for adults who have had a stroke and are between 24 and 72 hours after their symptoms began. Participants will receive a specific stroke treatment along with regular medical care to see if it improves their recovery.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 18 to 85 years old.
I have been diagnosed with acute ischemic stroke.
I have a score of 6 or higher on the NIH Stroke Scale.
It has been more than 24 hours and less than 72 hours since I was last well.
My pre-stroke disability score was between 0 and 1.
I am eligible for thrombectomy and medical management.
I can provide signed consent.
I expect to live at least 3 more months.
You may not be able to join if
I am currently in another research study.
My platelet count is less than 100,000/μl.
I have an intracranial tumor, large bleed, or abnormal blood vessel.
I have a significant mass effect in my brain.
I have a tear in my carotid artery that affects blood flow.
I have an intracranial stent in the same area of the brain.
I have strokes happening in more than one brain area.
My brain imaging shows evidence of a previous stroke.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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…
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.
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