NCT07746947 · Indiana University
PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry
What this study is about
Investigators are conducting a real world, observational, forward-looking, conducted at multiple hospitals study to better understand treatment for patients with MeVo and distal vessel occlusions in the U.S post publication of recent MeVO trials.
View original scientific description
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.
Primary outcome measures
Clinical outcomes based on distribution of modified Rankin Scale score(mRS)
Time frame: 3 months +/- 15 days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Informed consent: Within the first 72 hours after inclusion in the study
Exclusion criteria
- ASPECTS ≤ 5
- Any intracranial hemorrhage on initial CT head non contrast
- 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 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
- Indianapolis, Indiana
Collaborators
phenox Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations