Promise Registry: Prospective Study on Management of Ischemic Stroke Secondary to Mevo Registry

Study on Stroke Treatment for Blocked Brain Vessels

K
Kaustubh Limaye, MD

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase N/A
15 participants needed
2 Locations

Brief description of study

The primary objective of this study is to better understand the change in landscape, post clinical trials publication, of the management of medium vessel occlusion (MevO) causing acute ischemic strokes (AIS) in the first 24 hours. This study will help us better understand the “equipoise” in the eyes of practicing physicians across the U.S. We will include patients with MevO treated with mechanical thrombectomy as well as patients treated medically.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients presenting with symptoms of AIS in the anterior circulation secondary to MeVO will be screened at every participating site for inclusion in this pragmatic, observational, prospective registry. The definition of MeVO for this study includes the M2-M3 segments of the MCA, A2-A3 segments of the anterior cerebral artery (ACA), and P1-P3 segments of the posterior cerebral artery (PCA). The Neurovascular team will be made aware of the trial to assist with recruitment.  The patients will present in the ER or be an inpatient. The treating neurovascular physician may be a study investigator or will refer patient to a study investigator.  Study investigator will recruit /consent patient or refer patient to study coordinator for consent after discussing trial with patient or LAR.  

Detailed description of study

The study will collect information from patient's procedure, hospital stay, and brain imaging. 

Additionally:

  • Review patients medical records for up to 180 days after their stroke.
  • Record the results of neurological assessment that are already part of the patient's routine care before they leave the hospital and again at three (3) months and six (6) months.
  • Patients total participation will last about six months (180 days). 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute ischemic stroke
  • Age: 18 years - 85 years
  • Gender: All

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: 
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 13. Life expectancy is less than one year prior to stroke onset
14. 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 

This study investigates the management of ischemic strokes caused by medium vessel occlusion (MeVO). Ischemic stroke happens when a blood vessel supplying blood to the brain is blocked. MeVO refers to blockages in specific medium-sized arteries in the brain. The purpose of this study is to observe how these strokes are treated in real-life settings across the U.S.

Participants will have their medical records reviewed for up to 180 days after their stroke. The study will collect information from the patient's procedure, hospital stay, and brain imaging. Neurological assessments will be recorded as part of routine care before the patient leaves the hospital and again at three and six months.

  • Who can participate: Adults aged 18 to 85 with a sudden ischemic stroke who can get immediate treatment may join. Participants must have a treatable MeVO and meet certain medical rules, like a stroke scale score over 5.
  • Study details: Participants will have their medical records checked, and neurological assessments recorded as part of their routine care. The study will gather details from procedures, hospital stays, and brain scans.
  • Study timelines: The study will last 180 days.
Updated on 10 Jun 2026. Study ID: NEUR-IIR-PROMISE, 30747
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only