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OpenTrials
Completed

NCT Number: NCT06778226

ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Inclusion into any randomized control trials.

Treatment and study plan

Primary outcomes

  1. Modified Rankin Scale

    Time frame: 90 Days

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

Secondary outcomes

  1. Symptomatic Intracerebral Hemorrhage (sICH)

    Time frame: 48 hours

    Scores range from 0-3, higher scores indicate worse outcomes

  2. Change in National Institute of Health Stroke Scale (NIHSS)

    Time frame: 24 hours, 7 days

    Scores range 0-42; higher scores indicate worse outcomes

  3. Modified Rankin Scale

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Boston Medical Center
  • Brown University

Registry information

Acronym: TRIMIS

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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