ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion (TRIMIS)

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

Study Overview

• Status: Completed
• Conditions: Stroke

• Study Type: Observational
• Enrollment (Actual): 4827

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale	Scores range from 0-6. (0 = normal, 6 = dead).	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Intracerebral Hemorrhage (sICH)	Scores range from 0-3, higher scores indicate worse outcomes	48 hours
Change in National Institute of Health Stroke Scale (NIHSS)	Scores range 0-42; higher scores indicate worse outcomes	24 hours, 7 days
Modified Rankin Scale	Scores range from 0-6. (0 = normal, 6 = dead).	7 days

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Brown University; Boston Medical Center
• Investigators: Principal Investigator: Thanh Nguyen, MD, Boston Medical Center; Principal Investigator: Negar Asdaghi, MD, University of Miami; Principal Investigator: Shadi Yaghi, MD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 22, 2026
• Study Completion (Actual): April 22, 2026

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 20180038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No