ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion

NCT06778226 | Completed

• 1 other identifier: 20180038
• Study Type: observational
• Target: 4,827
• Locations: 1 country
• Sites: 3

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale

  Scores range from 0-6. (0 = normal, 6 = dead).

  90 Days

Secondary Outcomes (3)

• Symptomatic Intracerebral Hemorrhage (sICH)

  48 hours

• Change in National Institute of Health Stroke Scale (NIHSS)

  24 hours, 7 days

• Modified Rankin Scale

  7 days

Study Arms (3)

Immediate Endovascular Therapy

Data previously collected from medical records will be analyzed with the purpose of studying the efficiency of Immediate Endovascular Therapy. Length of the cohort is 6 years.

Delayed Endovascular Therapy

Data previously collected from medical records of participants will be analyzed with the purpose of studying the efficiency of Delayed Endovascular Therapy. Length of the cohort is 6 years.

Medical Management

Data previously collected from medical records of participants will be analyzed with the purpose of studying the efficiency of Medical Management. Length of the cohort is 6 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All acute stroke patients treated at participating sites in North America, South America, Europe, Asia, and Australia.

You may qualify if:

• Acute ischemic stroke in an adult patient (18 years of age or older).
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Findings on acute CT or MRI to suggest that the
• Patient has a severe or fatal or disabling illness that will impact decision regarding acute reperfusion therapies.
• Pregnancy.
• Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
• Stroke occurred as an inpatient.

Sponsors & Collaborators

• University of Miami: lead
• Brown University: collaborator
• Boston Medical Center: collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Negar Asdaghi, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Shadi Yaghi, MD

  Brown University

  PRINCIPAL INVESTIGATOR

• Thanh Nguyen, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: January 1, 2018
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)