Management of Ischemic StrokeNCT07746947
PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry
An observational study of Management of Ischemic Stroke and Medium Vessel Occlusion, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Management of Ischemic Stroke, Medium Vessel Occlusion
- Type of treatment
- Injection or infusion
- How many people
- 652 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2026to 11 Jul 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic Stroke
Who may be able to join
- 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:
- 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
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- Informed consent: Within the first 72 hours after inclusion in the study
- ASPECTS ≥5
- mRS≤2
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
Justin Bushnell, jbushnel@iu.edu
Sheryl Lynch, RN, slynch@iu.edu
About this study
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.
Read the detailed description
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. Investigators will include patients with MevO treated with mechanical thrombectomy as well as patients treated medically.
Study design: This prospective, multicenter, observational study will include patients treated with best medical treatment (BMT) and patients who are treated endovascularly (endovascular treatment (EVT)). Patients who receive intra-arterial thrombolytics will also be included in the EVT group. In addition, patients who have received intravenous thrombolysis (tPA or tNK) will be included and patients who have not received any treatment.
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).
- Keywords
- Ischemic Stroke Medium Vessel Occlusion, stroke, MeVO, thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment | Intra-arterial Treatment | |
| Medical Management | Intravenous Thrombolytic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months +/- 15 days
Secondary outcomes (3)
Utility weighted Modified Rankin scale (mRS) at 90 days
The Utility-Weighted Modified Rankin Scale (UW-mRS) is an advancement in the assessment of disability and functional independence for patients with neurological conditions. By incorporating patient preferences, it complements the traditional Modified Rankin Scale (mRS) by capturing individual preferences for specific health states.
Measured: 3 months +/- 15 days
Excellent functional recovery (mRS 0-1)
Excellent functional recovery (mRS 0-1): Functional independence is identified by pooling all patients achieving a) no stroke deficits (mRS of 0), b)minimal stroke deficits without any functional limitations (mRS of 1)
Measured: 3 months +/- 15 days
Functional independence (mRS 0-2)
Functional independence is identified by pooling all patients achieving a) no stroke deficits (mRS of 0), b) minimal stroke deficits without any functional limitations (mRS of 1) and c) functional limitations that do not interfere with independent living (mRS of 2) and illustrates being able to execute all day to day activities.
Measured: 3 months +/- 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start11 Jul 2026
- Primary completion11 Jul 2029 (estimated)
- Study completion11 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 652 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- phenox Inc.
- Responsible party
- Principal investigator, Kaustubh Limaye, Indiana University
- Investigators
- Kaustubh Limaye, MD, FAHA, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746947
- Sponsor's protocol ID
- 30747
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE Registry: PROspective Study on Management of Ischemic Stroke Secondary to mEvo Registry
- ClinicalTrials.gov ID
- NCT07746947
- Acronym / sponsor ID
- 30747
- Keywords
- Ischemic Stroke Medium Vessel Occlusion, stroke, MeVO, thrombectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- phenox Inc.
- Study start
- 11 Jul 2026 (actual)
- Primary completion
- 11 Jul 2029 (estimated)
- Study completion
- 11 Jul 2030 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Investigators will include patients with MevO treated with mechanical thrombectomy as well as patients treated medically.
Study design: This prospective, multicenter, observational study will include patients treated with best medical treatment (BMT) and patients who are treated endovascularly (endovascular treatment (EVT)). Patients who receive intra-arterial thrombolytics will also be included in the EVT group. In addition, patients who have received intravenous thrombolysis (tPA or tNK) will be included and patients who have not received any treatment.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Treatment | – | –Intra-arterial Treatment |
| Medical Management | – | –Intravenous Thrombolytic |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic Stroke
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Utility weighted Modified Rankin scale (mRS) at 90 days
Time frame: 3 months +/- 15 days
Excellent functional recovery (mRS 0-1)
Time frame: 3 months +/- 15 days
Functional independence (mRS 0-2)
Time frame: 3 months +/- 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaustubh Limaye, MD, FAHA principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Management of Ischemic Stroke and Medium Vessel Occlusion, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaustubh Limaye, MD, FAHA (317-963-7378, klimaye@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes based on distribution of modified Rankin Scale score(mRS) (time frame: 3 months +/- 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.