Clinical trial NCT06778226: ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion
Official title: ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Brown University
name: Boston Medical Center
First posted: 2025-01-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All acute stroke patients treated at participating sites in North America, South America, Europe, Asia, and Australia.

Brief summary: The purpose of TRIMIS is to study how a medical procedure by the name of endovascular therapy compares to medical treatment alone in patients with mild stroke and a blood vessel occlusion in the brain


Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke in an adult patient (18 years of age or older).
2. Onset (Last Seen Normal) time to treatment time \<24 hours or unknown Last Seen Normal in whom Endovascular Therapy could be considered per local radiographic guidelines.
3. Mild stroke defined as an NIH Stroke Scale ≤ 5 at the time of treatment decision.

   a. Patients with NIH Stroke Scale=0 can be included in the study if they have relevant abnormalities on neurological exam.
4. An acute intracranial vessel occlusion (Intracranial Internal Carotid Artery terminus (T or L clot), Middle Cerebral Artery (M1, M2, M3/beyond), Anterior Cerebral Artery (A1, A2, A3), V4, Basilar, Posterior Cerebral Artery) defined by non-invasive acute imaging (Computed Tomography, angiography (Computed Tomography Angiography) or Magnetic Resonance angiography (MRA)) that is neurologically relevant to the presenting symptoms and signs.

Exclusion Criteria:

1. Stroke symptoms due to another non-ischemic acute neurological condition such as seizure with Post-ictal Todd's paralysis or focal neurological signs due to severe hypo- or hyperglycemia.
2. Hyperdensity on Non-contrast Computed Tomography consistent with intracranial hemorrhage. Any clinical suspicion of any intracranial hemorrhage even in the absence of visible blood on baseline brain imaging.
3. Large acute stroke \>1/3 Middle Cerebral Artery territory or Alberta Stroke Programme Early CT score (ASPECTS\<6 or established frank hypodensity relevant to the presenting acute stroke already visible on baseline CT scan.
4. Findings on acute CT or MRI to suggest that the
5. Patient has a severe or fatal or disabling illness that will impact decision regarding acute reperfusion therapies.
6. Pregnancy.
7. Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
8. Stroke occurred as an inpatient.
9. Inclusion into any randomized control trials.

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 90 Days
Secondary outcomes:
measure: Symptomatic Intracerebral Hemorrhage (sICH)
timeFrame: 48 hours
measure: Change in National Institute of Health Stroke Scale (NIHSS)
timeFrame: 24 hours, 7 days
measure: Modified Rankin Scale
timeFrame: 7 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: University of Miami
name: Negar Asdaghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Shadi Yaghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Thanh Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: