Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Trial ID or NCT#
NCT02586415
Status
NOT RECRUITING
Purpose
This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.
Official Title
Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3
Eligibility Criteria
Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic stroke 2. Age 18-90 years 3. Baseline NIHSSS is ≥ 6 and remains ≥6 immediately prior to randomization 4. Endovascular treatment can be initiated (femoral puncture) between 6 and 16 hours of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits). 5. modified Rankin Scale less than or equal to 2 prior to qualifying stroke (functionally independent for all ADLs) 6. Patient/Legally Authorized Representative has signed the Informed Consent form. Clinical
Exclusion Criteria:
- 1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA >4.5 hours after time last known well 7. Treated with tPA 3-4.5 hours after last known well AND any of the following; age >80, current anticoagulant use, history of diabetes or prior stroke, NIHSS >25 8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR > 30 ml/min). 9. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 10. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol) 11. Baseline platelet count < 50,000/uL 12. Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg) 13. Current participation in another investigational drug or device study 14. Presumed septic embolus; suspicion of bacterial endocarditis 15. Clot retrieval attempted using a neurothrombectomy device prior to 6 hrs from symptom onset 16. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Neuroimaging Inclusion Criteria: 1. ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA AND 2. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume* is >/= 15 ml) Alternative neuroimaging inclusion criteria (if perfusion imaging or CTA/MRA is technically inadequate): A) If CTA (or MRA) is technically inadequate: Tmax>6s perfusion deficit consistent with an ICA or MCA-M1 occlusion AND Target Mismatch Profile (ischemic core volume is < 70 ml, mismatch ratio is >1.8 and mismatch volume is >15 ml as determined by RAPID software) B) If MRP is technically inadequate: ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA (or CTA, if MRA is technically inadequate and a CTA was performed within 60 minutes prior to the MRI) AND DWI lesion volume < 25 ml C) If CTP is technically inadequate: Patient can be screened with MRI and randomized if neuroimaging criteria are met. Neuroimaging Exclusion Criteria: 1. ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria) 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 3. Significant mass effect with midline shift 4. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 5. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 6. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
Investigator(s)
Maarten Lansberg, MD, PhD
Stroke and vascular neurologist,
General neurologist
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Gregory W. Albers, MD
Stroke and vascular neurologist
Coyote Foundation Professor and Professor, by courtesy, of Neurosurgery
Jeremy J. Heit, MD, PhD
Interventional neuroradiologist
Associate Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery
Neil Schwartz, MD, PhD
Stroke and vascular neurologist,
General neurologist
Clinical Professor, Neurology & Neurological Sciences
Clinical Professor (By courtesy), Neurosurgery
View on ClinicalTrials.gov
