143
Participants
Start Date
September 5, 2020
Primary Completion Date
September 30, 2025
Study Completion Date
September 30, 2025
Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device
"Treatment initiation is defined as the date and time of arterial puncture. Femoral artery puncture will occur within 45 minutes of randomization and no longer than 90 minutes after the completion of the qualifying imaging. It must occur before 8 hours since the subject was last known well.The initial procedure will be performed using only the EmboTrap II Retriever for the first two passes, and a third pass is encouraged. Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two hours of arterial access.~All subjects, regardless of randomization arm, will receive best medical management based on current American Heart Association, Canadian, or European guidelines according to their geographic location."
Initial medical management (iMM)
"Patients will receive standard medical therapy based on current AHA guidelines. For patients who are treated with intravenous tissue plasminogen activator (rtPA), the sites' post-rtPA protocol will be followed. Rescue mechanical thrombectomy (rMT) is allowed for patients initially assigned to iMM if they suffer major neurological worsening that clearly requires an intra-arterial intervention in the judgment of the treating team.~All subjects, regardless of randomization arm, will receive best medical management based on current American Heart Association, Canadian, or European guidelines according to their geographic location."
Icahn School of Medicine at Mount Sinai, New York
Albany Medical Center, Albany
University at Buffalo Neurosurgery/ Kaleida Health, Buffalo
Prisma Health-Upstate, Greenville
Grady Health System (non-CRN), Atlanta
Baptist Health Jacksonville FL, Jacksonville
University of Miami Miller School of Medicine, Miami
Semmes Murphey Foundation, Memphis
Baptist Health Lexington, Lexington
Ohio State Wexner Medical Center, Columbus
Riverside Medical Center, OhioHealth Research Institute, Columbus
Cleveland Clinic, Cleveland
University of Cincinnati, Cincinnati
Indiana University, Bloomington
Henry Ford Health System, Detroit
McLaren Health Care Corporation, Grand Blanc
University of Iowa, Iowa City
Advocate Aurora Health, Downers Grove
Rush University Medical Center: University Neurosurgery, Chicago
Washington University School of Medicine, St Louis
Universitäts Klinikum Heidelberg, Heidelberg
VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen, Harlingen
Texas Tech University Health Sciences Center at El Paso, El Paso
Ludwig Maximilian University, Department of Neurology, München
Providence Little Company of Mary Medical Center, Torrance
University of Massachusetts Medical Center, Worcester
JFK Neurosciences Center, Edison
Thomas Jefferson University, Woodbury
University of Calgary and Foothills Medical Centre, Calgary
University of Alberta Hospital, Edmonton
University of Manitoba, Winnipeg
London Health Sciences Centre, London
Montreal Neurological Institute and Hospital, Montreal
University of Saskatchewan, Saskatoon
University of Calgary
OTHER
University of Cincinnati
OTHER
Heidelberg University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Emory University
OTHER