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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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
143 participants
INTERVENTIONAL
2020-09-05
2025-09-30
Brief Summary
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Detailed Description
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This study will test the hypothesis that patients presenting within 8 hours of onset with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Immediate mechanical thrombectomy(iMT)
Treatment initiation within 8 hours of symptom onset. Arterial puncture and revascularization will be performed using EmboTrap II Retriever. The procedure will be completed within two hours of arterial access.
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)
Standard medical therapy based on current AHA (American Heart Association) guidelines. 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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of an objective neurological deficit
3. Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.5 hours from symptom onset
4. Proximal Intracranial Artery Occlusion on Imaging by NCCT/CTA or MRI/MRA showing complete occlusion of the intracranial ICA, M1, or an "M1-like" M2 vessel with or without tandem cervical lesion. Notably, "M1-like" M2 vessel occlusions are defined functionally for the trial as following:
1. On CTA: Occlusion of both branches after MCA division (both M2s occluded) or occlusion of the larger diameter M2 branch . In case of trifurcations, either the two largest M2 branches are occluded or the occluded M2 has a larger diameter than the combined diameter of the two other M2s . Notably, the M2 origins are defined by the first branching point in the MCA other than the anterior temporal artery rather than by anatomic landmarks (e.g., horizontal versus insular location).
or
2. If mCTA or CTP performed (optional): a M2 occlusion which supplies a large proportion of the MCA territory by evidence of either:
i. The bulk (\>2/3) of the MCA territory has evidence of delayed washout on multiphase CT or ii. Perfusion imaging shows a hypoperfusion lesion volume involving a significant proportion of the MCA territory defined as Tmax \>4 sec lesion of ≥100 mL
5. Baseline Infarct Core of either:
1. Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or
2. Baseline Infarct Core Volume of \< 70cc on either CTP (Volume of rCBF \<30%) or DWI if quantitative software tools are available (neither test is mandatory for study)
Exclusion Criteria
2. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH)
3. Any imaging findings suggestive of futile recanalization in the judgment of the local investigator
4. High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD
5. Premorbid disability (mRS ≥3)
6. Inability to randomize within 8 hours of last known well
7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
8. Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol)
9. Known coagulation disorders as defined as platelet count \<100,000/uL
10. Known renal failure as defined as serum creatinine levels \> 3.0 mg/dL
11. Presumed septic embolus or suspicion of bacterial endocarditis
12. 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.
13. Participation in another investigational treatment study in the previous 30 days
14. Intubation and mechanical ventilation prior to study enrollment is medically indicated
15. History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
16. Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management)
17. Known pregnancy
18. Prisoner or incarceration
19. Known acute symptomatic COVID-19 infection
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
University of Cincinnati
OTHER
Heidelberg University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Emory University
OTHER
Responsible Party
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Raul Gomes Nogueira
Professor
Principal Investigators
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Raul G Nogueira, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Providence Little Company of Mary Medical Center
Torrance, California, United States
Baptist Health Jacksonville FL
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Grady Health System (non-CRN)
Atlanta, Georgia, United States
Rush University Medical Center: University Neurosurgery
Chicago, Illinois, United States
Advocate Aurora Health
Downers Grove, Illinois, United States
Indiana University
Bloomington, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
McLaren Health Care Corporation
Grand Blanc, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
JFK Neurosciences Center
Edison, New Jersey, United States
Thomas Jefferson University
Woodbury, New Jersey, United States
Albany Medical Center
Albany, New York, United States
University at Buffalo Neurosurgery/ Kaleida Health
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State Wexner Medical Center
Columbus, Ohio, United States
Riverside Medical Center, OhioHealth Research Institute
Columbus, Ohio, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Semmes Murphey Foundation
Memphis, Tennessee, United States
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, United States
VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen
Harlingen, Texas, United States
University of Calgary and Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Universitäts Klinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Ludwig Maximilian University, Department of Neurology
München, Bavaria, Germany
Countries
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References
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Seners P, Cereda CW. Thrombectomy in Stroke With a Large Vessel Occlusion and Mild Symptoms: "Striving to Better, Oft We Mar What's Well?". Stroke. 2023 Sep;54(9):2276-2278. doi: 10.1161/STROKEAHA.123.044205. Epub 2023 Aug 1. No abstract available.
Feil K, Matusevicius M, Herzberg M, Tiedt S, Kupper C, Wischmann J, Schonecker S, Mengel A, Sartor-Pfeiffer J, Berger K, Dimitriadis K, Liebig T, Dieterich M, Mazya M, Ahmed N, Kellert L. Minor stroke in large vessel occlusion: A matched analysis of patients from the German Stroke Registry-Endovascular Treatment (GSR-ET) and patients from the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register (SITS-ISTR). Eur J Neurol. 2022 Jun;29(6):1619-1629. doi: 10.1111/ene.15272. Epub 2022 Feb 19.
Other Identifiers
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IRB00107210
Identifier Type: -
Identifier Source: org_study_id
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