Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT07746947

Conditions

Management of Ischemic Stroke

Medium Vessel Occlusion

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Investigators are conducting a real world, observational, prospective, multicenter study to better understand treatment for patients with MeVo and distal vessel occlusions in the U.S post publication of recent MeVO trials.

Conditions

Management of Ischemic Stroke

Medium Vessel Occlusion

Study ID

NCT07746947

Start date

Jul 11, 2026

Status verified date

Jul, 2026

Completion date

Jul 11, 2030

Anticipated

Primary completion date

Jul 11, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion

1. Acute ischemic stroke clinically eligible for immediate EVT
2. Age ≥18 - 85 years of age
3. Time from onset (or last-seen-well) to 24 hours
4. Disabling stroke defined as follows:

A. Baseline National Institutes of Health Stroke Scale (NIHSS) score >5 B. Baseline NIHSS 3-5 with disabling deficit (e.g., hemianopia, aphasia, loss of hand function) as determined and agreed upon by two physicians in context of the patient's life
5. Confirmed treatable MeVO based on neurovascular non-invasive imaging (CTA or MRA), at one or more of the following locations: M2 or M3 segment, A2 or A3 segment, P1, P2 or P3 segment
6. Informed consent: Within the first 72 hours after inclusion in the study
7. ASPECTS ≥5
8. mRS≤2

Exclusion Criteria:

1. Age >86
2. ASPECTS ≤ 5
3. Any intracranial hemorrhage on initial CT head non contrast
4. mRS≥3
5. Known pregnancy (local protocol to determine if patient is pregnant at the time of stroke)
6. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
7. CT evidence of the following conditions:

  • Midline shift or herniation
  • Mass effect with effacement of the ventricles
8. Acute bilateral strokes
9. Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
10. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization.
11. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
12. Baseline platelet count <80,000 per microliter (µl)
13. Life expectancy is less than one year prior to stroke onset14. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes

15\. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed

Study Design

Enrollment

652 participants

Anticipated

Interventions and Outcome Measures

Arms

Endovascular Treatment

Intra-arterial Treatment

Medical Management

Intravenous Thrombolytic

Primary outcome measure

  • Clinical outcomes based on distribution of modified Rankin Scale score(mRS) [ Time Frame: 3 months +/- 15 days ]

Central Contacts and Locations

Central contacts

Kaustubh Limaye, MD, FAHA

317-963-7378klimaye@iu.edu

Locations

IU Health Neuroscience Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Justin Bushnell

jbushnel@iu.edu

Sheryl Lynch, RN

slynch@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Keywords

  • Ischemic Stroke Medium Vessel Occlusion
  • stroke
  • MeVO
  • thrombectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-05.