Management of Ischemic Stroke, Medium Vessel Occlusion
Conditions
Keywords
Ischemic Stroke Medium Vessel Occlusion, stroke, MeVO, thrombectomy
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.
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).
Interventions
None listed
Sponsors
Indiana University
phenox Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
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 \<80,000 per microliter (µl) 13. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes based on distribution of modified Rankin Scale score(mRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility weighted Modified Rankin scale (mRS) at 90 days | 3 months +/- 15 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. |
| Excellent functional recovery (mRS 0-1) | 3 months +/- 15 days | 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) |
| Functional independence (mRS 0-2) | 3 months +/- 15 days | 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. |
Countries
United States
Contacts
CONTACTKaustubh Limaye, MD, FAHA
PRINCIPAL_INVESTIGATORKaustubh Limaye, MD, FAHA
Indiana University
Outcome results
None listed