ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion

Active, not recruiting

• Conditions: Stroke

• Registration Number: NCT06778226
• Lead Sponsor: University of Miami

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	90 Days	Scores range from 0-6. (0 = normal, 6 = dead).

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Miami; 🇺🇸 Miami, Florida, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States