Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1600 participants
INTERVENTIONAL
2025-01-31
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata
Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies:
* Endovascular Therapy (EVT)
* Medical Management (MM)
Endovascular thrombectomy with any FDA-approved category POL or NRY device
Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
Medical Management
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata
Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3 occlusion will be randomized to receive one of two strategies:
* Endovascular Therapy (EVT)
* Medical Management (MM)
Endovascular thrombectomy with any FDA-approved category POL or NRY device
Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
Medical Management
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Interventions
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Endovascular thrombectomy with any FDA-approved category POL or NRY device
Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
Medical Management
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Likely causative intracranial large or medium vessel occlusion
1\. Age 18 years or older 2. Pre-stroke modified Rankin Scale score 0-2 3. Presentation to enrolling hospital within 24 hours of last known well/stroke onset 4. Able to initiate arterial puncture within 2 hours from qualifying CTA/MRA or CTP/MRP imaging
\*CT/MR and qualifying CTA/MRA or CTP/MRP should be repeated if more than 120 minutes have elapsed since the imaging and randomization has not been performed. The exception is for LVO Mild deficit/Low NIHSS 0-5 for which imaging would only need to be repeated if there has been significant improvement in the NIHSS prior to randomization.
5\. Has one of the following presentations:
1. LVO patients with mild deficits/low NIHSS (must have both):
1. Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0)
2. Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)
2. Medium/Distal Vessel Occlusion:
1. Visualized complete occlusion or perfusion deficit (Tmax \> 4s) supportive of a cortical branch occlusion in one of the following vessels:
i) Non-dominant/Co-dominant M2 (defined as serving \< 50% of entire overall MCA territory) ii) M3
2. If symptom onset is \> 6h, the core must be less than 50% of the territory supplied by the occluded vessel as evident by either:
i) Hypodensity and loss of grey-white border on NCCT or ii)ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP
3. NIHSS \> =8
Exclusion Criteria
2. Prisoners/incarcerated
DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:
Each domain may have additional eligibility criteria.
1. Clinical
1. Presumed septic embolus; suspicion of bacterial endocarditis
2. Seizure at stroke onset or between onset and enrollment
3. Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy
4. Intracranial occlusion suspected to be chronic, based on history and/or imaging
5. Intracranial dissection, based on history and/or imaging
6. Cerebral vasculitis, based on history and/or imaging
7. Known pregnancy
8. Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
9. Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment
10. Known or high suspicion for underlying intracranial atherosclerotic disease (ICAD)
2. Laboratory
a. Known platelet count \<100,000/uL
3. Imaging
1. CT ASPECT score \<6 (MRI ASPECT score \<7)
2. Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy.
3. Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
4. Tandem occlusions
5. Significant mass effect with midline shift (\>5mm)
6. Evidence of intra-cranial tumor (except small meningioma defined as (1) \<=3 cm, (2) asymptomatic) as confirmed on CT/MRI)
7. Evidence of acute intracranial hemorrhage
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Cincinnati
OTHER
University of Virginia
OTHER
Berry Consultants
OTHER
University of California, Los Angeles
OTHER
MOUNT SINAI HOSPITAL
OTHER
The Cooper Health System
OTHER
University of Pittsburgh Medical Center
OTHER
Stony Brook University
OTHER
University at Buffalo
OTHER
Medical University of South Carolina
OTHER
Responsible Party
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Jordan Elm
Research Professor-Faculty
Principal Investigators
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Jordan J Elm, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Eva A Mistry, MBBS, MSCI
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Pooja Khatri, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Colin P Derdeyn, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Jeffery L Saver, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Tudor G Jovin, MD
Role: PRINCIPAL_INVESTIGATOR
The Cooper Health System
Raul G Nogueira, MD, FAHA
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
David Fiorella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Adnan Siddiqui, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
J Mocco, MD, MS
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
UCSD Health La Jolla
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States
Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Jackson Memorial Hospital
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
NYU Langone Hospital
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Medical City Plano
Plano, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
UVA Medical Center
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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STEP
Identifier Type: -
Identifier Source: org_study_id
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