Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Promising Management of Medium Vessel Occlusion in Ischemic Stroke: Real-World Registry

Official title: PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry

Run by Indiana University · NCT07746947 · Data updated 2026-11-12

This study tests how MeVO-related stroke is managed in real-world practice across multiple U.S. centers, including both medical therapy and mechanical interventions.

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment652 (estimated)
SponsorIndiana University
Academic / other
Locations1 site (Indianapolis, Indiana)
StatusRecruiting
StartedJuly 11, 2026
Main results expectedJuly 11, 2029
Study endsJuly 11, 2030
Registry record updatedAugust 5, 2026
Trial IDNCT07746947 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–85 with acute ischemic stroke due to MeVO (M2–M3 MCA, A2–A3 ACA, P1–P3 PCA) who are eligible for EVT or medical therapy.

Probably not a fit

Patients who do not meet criteria or are not candidates for EVT or medical therapy may not gain direct benefit from the study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter registry observing real-world care for acute ischemic stroke due to medium vessel occlusions (MeVO). It includes patients treated with best medical therapy alone or with endovascular treatment, with or without intra-arterial or intravenous thrombolytics. The goal is to understand how management strategies and outcomes have changed after recent MeVO trials and to capture physician decision-making in routine practice. Data will come from patients screened at participating sites within 24 hours of onset, with broad eligibility reflecting typical clinical scenarios. No experimental interventions are defined within the protocol; the study focuses on observational data to describe care patterns and outcomes.

Why it matters

Potential benefit: If successful, the registry could clarify real-world treatment patterns and help guide future guidelines for MeVO-related strokes.

How similar studies have gone: Prior MeVO trials have informed practice patterns; this registry extends understanding by documenting real-world management and outcomes.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • IU Health Neuroscience Center
    Indianapolis, Indiana, United States
    Recruiting

Study contacts

  • Principal investigator: Kaustubh Limaye, MD, FAHA — Indiana University
  • Study coordinator: Kaustubh Limaye, MD, FAHA
  • Email: klimaye@iu.edu
  • Phone: 317-963-7378

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Intra-arterial Thrombolysis for Acute Ischemic Stroke with Medium Vessel Occlusion

    This trial tests whether delivering a clot-busting medicine directly into the brain’s medium vessels helps improve outcomes for adults with acute ischemic stroke caused by MeVO, on top of standard care.

    Recruiting Phase 3 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07668323

  • Tenecteplase delivered into the artery for acute medium-vessel stroke

    This trial will test whether giving tenecteplase directly into the blocked artery helps adults with acute medium-vessel ischemic stroke recover better when treated within 24 hours.

    Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07357987

  • Intra-arterial tenecteplase for medium-vessel occlusion stroke

    This trial will test whether delivering tenecteplase directly into the blocked medium brain artery helps adults with medium-vessel ischemic stroke recover better when treated within 24 hours of symptom onset.

    Recruiting Phase 2/3 Tongji Hospital · Wuhan, Hubei · NCT07302854

  • Intra-arterial clot-dissolving treatment for medium-vessel ischemic stroke

    The team will test whether giving tenecteplase directly into the artery helps adults with acute ischemic stroke caused by medium-vessel blockage or severe narrowing.

    Recruiting at 6 sites The Second Hospital of Anhui Medical University · Fuyang, Anhui and 5 other locations · NCT07185022

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.