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

NCT07746947 | Recruiting

• 1 other identifier: 30747
• Study Type: observational
• Target: 652
• Locations: 1 country
• Sites: 1

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

Medium Vessel Occlusion; Management of Ischemic Stroke

Keywords

Ischemic Stroke Medium Vessel Occlusion; stroke; MeVO; thrombectomy

Outcome Measures

Primary Outcomes (1)

• Clinical outcomes based on distribution of modified Rankin Scale score(mRS)

  The modified Rankin Scale (a 7-point scoring system, 0 indicates no residual stroke symptoms and 6 represents death) is assessed through patient/caregiver interview by trained personnel.

  3 months +/- 15 days

Secondary Outcomes (3)

• Utility weighted Modified Rankin scale (mRS) at 90 days

  3 months +/- 15 days

• Excellent functional recovery (mRS 0-1)

  3 months +/- 15 days

• Functional independence (mRS 0-2)

  3 months +/- 15 days

Other Outcomes (3)

• Symptomatic intracranial hemorrhage (sICH):

  24 hours +/- 6 hours

• Mortality

  1 year

• Intracranial hemorrhage post treatment

  24 hours +/- 6 hours

Study Arms (2)

Endovascular Treatment

Intra-arterial Treatment

Medical Management

Intravenous Thrombolytic

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ischemic Stroke

You may qualify if:

• Acute ischemic stroke clinically eligible for immediate EVT
• Age ≥18 - 85 years of age
• Time from onset (or last-seen-well) to 24 hours
• 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
• 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
• ASPECTS ≥5
• mRS≤2

You may not qualify if:

• Age \>86
• ASPECTS ≤ 5
• Any intracranial hemorrhage on initial CT head non contrast
• mRS≥3
• Known pregnancy (local protocol to determine if patient is pregnant at the time of stroke)
• Known severe allergy (more than a rash) to contrast media uncontrolled by medications
• CT evidence of the following conditions:
• Midline shift or herniation
• Mass effect with effacement of the ventricles
• Acute bilateral strokes
• Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
• Intracranial tumors other than small meningioma that does not require surgery for one year post randomization.
• 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
• Baseline platelet count \<80,000 per microliter (µl)
• 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

Sponsors & Collaborators

• Indiana University: lead
• phenox Inc.: collaborator

Study Sites (1)

IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kaustubh Limaye, MD, FAHA

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaustubh Limaye, MD, FAHA

CONTACT

317-963-7378; klimaye@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology, Neurological Surgery and Radiology

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 5, 2026
• Study Start: July 11, 2026
• Primary Completion (Estimated): July 11, 2029
• Study Completion (Estimated): July 11, 2030
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)