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Compares treatment options for Acute Ischemic Stroke
Official title Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well
ClinicalTrials.gov ID: NCT07115940
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- General
- 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
You likely can't join if
- Current participation in another investigational treatment 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...
- 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...
- Evidence of intracranial tumor (except small meningioma \<3cm without signs of edema or inflammation), acute intracranial hemorrhage, or...
See the full eligibility criteria
- General
- 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...
- Current participation in another investigational treatment 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...
- 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...
- 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 \ 150 ml OR MR Diffusion ischemic core (ADC \ 150ml #If the perfusion software at enrollment center uses another threshold/measure to define ischemic core, please use that measure to...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- St Louis, Missouri, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Morgantown, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Kansas City, Kansas, United States; St Louis, Missouri, United States; Providence, Rhode Island, United States; Dallas, Texas, United States; Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.