ThRombectomy In Mild Ischemic Stroke With a Visible Intracranial veSsel Occlusion

NCT ID: NCT06778226

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2026-05-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Negar Asdaghi

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Negar Asdaghi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Shadi Yaghi, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Thanh Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

University of Miami

Miami, Florida, United States

Boston Medical Center

Boston, Massachusetts, United States

Brown University

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

20180038

Identifier Type: -

Identifier Source: org_study_id