Endovascular Therapy for Low NIHSS Ischemic Strokes

Last updated: March 27, 2025
Sponsor: Emory University
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Cerebral Ischemia

Stroke

Thrombosis

Treatment

Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device

Initial medical management (iMM)

Clinical Study ID

NCT04167527
IRB00107210
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 years or older

  2. Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of anobjective neurological deficit

  3. Patients eligible for intravenous rt-PA should receive this therapy as soon aspossible and no later than 4.5 hours from symptom onset

  4. 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:

  5. 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

  6. 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

  7. Baseline Infarct Core of either:

  8. Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or

  9. 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:

  1. NIHSS ≥6

  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 thelocal investigator

  4. High degree of suspicion of intracranial arterial disease (ICAD), such as evidenceof 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 anendovascular procedure or poses a significant hazard to the subject if anendovascular 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 medicallyindicated

  15. History of drug or alcohol use or dependence that, in the opinion of the siteinvestigator, 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

Study Design

Total Participants: 143
Treatment Group(s): 2
Primary Treatment: Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device
Phase: 2/3
Study Start date:
September 05, 2020
Estimated Completion Date:
September 30, 2025

Study Description

Currently, the vast majority of these patients do not receive immediate vessel imaging with either CT- or MR-angiography. However, acute ischemic stroke patients with low NIHSS who harbor a large vessel occlusion (LVO) later decline in 20-40% of cases, and/or have underappreciated impairments related to their relatively mild strokes. Similarly, LVO patients presenting with a transient ischemic attack (TIA) are under increased risk of clinical deterioration. Such patients with apparent good collateral circulation, and hence a substantial perfusion of the vascular territory of the occluded large artery, likely have the most to gain from endovascular revascularization. At the same time, this collateral perfusion may allow for more frequent recanalization, either spontaneously or by intravenous (IV) rtPA. Experience with immediate mechanical thrombectomy (iMT) in the LVO mild stroke target population is limited.

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).

Connect with a study center

  • University of Calgary and Foothills Medical Centre

    Calgary, Alberta T2N 5A6
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • University of Manitoba

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Trillium Health Partners

    Mississauga, Ontario L5B 2P7
    Canada

    Site Not Available

  • The Ottawa Hospital Civic Campus

    Ottawa, Ontario K1Y 4E9
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montréal, Quebec H3A 2B4
    Canada

    Site Not Available

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Universitätsklinikum Freiburg, Klinik für Neurologie

    Freiburg im Breisgau, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Universitäts Klinikum Heidelberg

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Ludwig Maximilian University, Department of Neurology

    München, Bayern 81377
    Germany

    Site Not Available

  • Institute of Neuroradiology, University Hospital Frankfurt

    Frankfurt Am Main, Hessen 60528
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Klinikum Osnabrueck, Department of Neurology

    Osnabrück, Niedersachsen 49076
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • University Hospital Carl Gustav Carus Dresden Dresden, Department of Neurology

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • University Hospital Schleswig-Holstein, Campus Kiel

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Gesundheit Nord Klinikum Bremen-Mitte

    Bremen, 28205
    Germany

    Site Not Available

  • Providence Little Company of Mary Medical Center

    Torrance, California 90503
    United States

    Site Not Available

  • Baptist Health Jacksonville FL

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Grady Health System (non-CRN)

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Rush University Medical Center: University Neurosurgery

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Advocate Aurora Health

    Downers Grove, Illinois 60068
    United States

    Site Not Available

  • Indiana University

    Bloomington, Indiana 47401
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52241
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • University of Massachusetts Medical Center

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Michigan Medicine Comprehensive Stroke Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • McLaren Health Care Corporation

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • JFK Neuroscience Institute

    Edison, New Jersey 08820
    United States

    Site Not Available

  • JFK Neurosciences Center

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Thomas Jefferson University

    Woodbury, New Jersey 08096
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • University at Buffalo Neurosurgery/ Kaleida Health

    Buffalo, New York 14203
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Ohio State Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Riverside Medical Center, OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Prisma Health-Upstate

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Semmes Murphey Foundation

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center at El Paso

    El Paso, Texas 79905
    United States

    Site Not Available

  • VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen

    Harlingen, Texas 78550
    United States

    Site Not Available

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