Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

Not Recruiting

Trial ID: NCT02586415


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

Stanford Investigator(s)

Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD

Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Gregory W. Albers, MD
Gregory W. Albers, MD

Coyote Foundation Professor and Professor, by courtesy, of Neurosurgery

Jeremy J. Heit, MD, PhD
Jeremy J. Heit, MD, PhD

Associate Professor of Radiology (Neuroimaging and Neurointervention) and, by courtesy, of Neurosurgery

Neil Schwartz, MD, PhD
Neil Schwartz, MD, PhD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery


Clinical Inclusion Criteria:

   1. Signs & symptoms consistent w/ the diagnosis of acute anterior circulation ischemic

   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

   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

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


   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

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

   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

   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).


procedure: Endovascular Thrombectomy

device: Trevo Retriever

device: Solitaire™ FR Revascularization Device

device: Penumbra thrombectomy system

device: Covidien MindFrame Capture Revascularization Device

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305