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Recruiting NCT07746947

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

— Observational Management of Ischemic Stroke Medium Vessel Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Management of Ischemic Stroke, Medium Vessel Occlusion. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Primary outcome measures

  • Clinical outcomes based on distribution of modified Rankin Scale score(mRS) [Time frame: 3 months +/- 15 days]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion

  • 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
  • ASPECTS ≥5
  • mRS≤2

Exclusion criteria

  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • IU Health Neuroscience Center — Indianapolis

Identifiers

NCT: NCT07746947 · 30747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗