Phase
Condition
Cerebral Ischemia
Stroke
Thrombosis
Treatment
Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device
Initial medical management (iMM)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 years or older
Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of anobjective neurological deficit
Patients eligible for intravenous rt-PA should receive this therapy as soon aspossible and no later than 4.5 hours from symptom onset
Proximal Intracranial Artery Occlusion on Imaging by NCCT/CTA or MRI/MRA showingcomplete occlusion of the intracranial ICA, M1, or an "M1-like" M2 vessel with orwithout tandem cervical lesion. Notably, "M1-like" M2 vessel occlusions are definedfunctionally for the trial as following:
On CTA: Occlusion of both branches after MCA division (both M2s occluded) orocclusion of the larger diameter M2 branch . In case of trifurcations, eitherthe two largest M2 branches are occluded or the occluded M2 has a largerdiameter than the combined diameter of the two other M2s . Notably, the M2origins are defined by the first branching point in the MCA other than theanterior temporal artery rather than by anatomic landmarks (e.g., horizontalversus insular location).or
If mCTA or CTP performed (optional): a M2 occlusion which supplies a largeproportion of the MCA territory by evidence of either: i. The bulk (>2/3) of the MCA territory has evidence of delayed washout onmultiphase CT or ii. Perfusion imaging shows a hypoperfusion lesion volume involvinga significant proportion of the MCA territory defined as Tmax >4 sec lesion of ≥100mL
Baseline Infarct Core of either:
Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or
Baseline Infarct Core Volume of < 70cc on either CTP (Volume of rCBF <30%) orDWI if quantitative software tools are available (neither test is mandatory forstudy)
Exclusion
Exclusion Criteria:
NIHSS ≥6
Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH)
Any imaging findings suggestive of futile recanalization in the judgment of thelocal investigator
High degree of suspicion of intracranial arterial disease (ICAD), such as evidenceof multifocal ICAD
Premorbid disability (mRS ≥3)
Inability to randomize within 8 hours of last known well
Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol)
Known coagulation disorders as defined as platelet count <100,000/uL
Known renal failure as defined as serum creatinine levels > 3.0 mg/dL
Presumed septic embolus or suspicion of bacterial endocarditis
Any other condition that, in the opinion of the investigator, precludes anendovascular procedure or poses a significant hazard to the subject if anendovascular procedure was performed.
Participation in another investigational treatment study in the previous 30 days
Intubation and mechanical ventilation prior to study enrollment is medicallyindicated
History of drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements
Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management)
Known pregnancy
Prisoner or incarceration
Known acute symptomatic COVID-19 infection
Study Design
Study Description
Connect with a study center
University of Calgary and Foothills Medical Centre
Calgary, Alberta T2N 5A6
CanadaSite Not Available
University of Alberta Hospital
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
University of Manitoba
Winnipeg, Manitoba R3E 3P4
CanadaSite Not Available
London Health Sciences Centre
London, Ontario N6A 5A5
CanadaSite Not Available
Trillium Health Partners
Mississauga, Ontario L5B 2P7
CanadaSite Not Available
The Ottawa Hospital Civic Campus
Ottawa, Ontario K1Y 4E9
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Montreal Neurological Institute and Hospital
Montréal, Quebec H3A 2B4
CanadaSite Not Available
University of Saskatchewan
Saskatoon, Saskatchewan S7N 0W8
CanadaSite Not Available
Universitätsklinikum Freiburg, Klinik für Neurologie
Freiburg im Breisgau, Baden-Württemberg 79106
GermanySite Not Available
Universitäts Klinikum Heidelberg
Heidelberg, Baden-Württemberg 69120
GermanySite Not Available
Ludwig Maximilian University, Department of Neurology
München, Bayern 81377
GermanySite Not Available
Institute of Neuroradiology, University Hospital Frankfurt
Frankfurt Am Main, Hessen 60528
GermanySite Not Available
Universitätsmedizin Göttingen
Göttingen, Niedersachsen 37075
GermanySite Not Available
Klinikum Osnabrueck, Department of Neurology
Osnabrück, Niedersachsen 49076
GermanySite Not Available
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen 45147
GermanySite Not Available
University Hospital Carl Gustav Carus Dresden Dresden, Department of Neurology
Dresden, Sachsen 01307
GermanySite Not Available
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein 24105
GermanySite Not Available
Gesundheit Nord Klinikum Bremen-Mitte
Bremen, 28205
GermanySite Not Available
Providence Little Company of Mary Medical Center
Torrance, California 90503
United StatesSite Not Available
Baptist Health Jacksonville FL
Jacksonville, Florida 32207
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Grady Health System (non-CRN)
Atlanta, Georgia 30322
United StatesSite Not Available
Rush University Medical Center: University Neurosurgery
Chicago, Illinois 60612
United StatesSite Not Available
Advocate Aurora Health
Downers Grove, Illinois 60068
United StatesSite Not Available
Indiana University
Bloomington, Indiana 47401
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52241
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
University of Massachusetts Medical Center
Worcester, Massachusetts 01605
United StatesSite Not Available
Michigan Medicine Comprehensive Stroke Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
McLaren Health Care Corporation
Grand Blanc, Michigan 48439
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
JFK Neuroscience Institute
Edison, New Jersey 08820
United StatesSite Not Available
JFK Neurosciences Center
Edison, New Jersey 08820
United StatesSite Not Available
Thomas Jefferson University
Woodbury, New Jersey 08096
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesSite Not Available
University at Buffalo Neurosurgery/ Kaleida Health
Buffalo, New York 14203
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Riverside Medical Center, OhioHealth Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Prisma Health-Upstate
Greenville, South Carolina 29601
United StatesSite Not Available
Semmes Murphey Foundation
Memphis, Tennessee 38120
United StatesSite Not Available
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas 79905
United StatesSite Not Available
VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen
Harlingen, Texas 78550
United StatesSite Not Available
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