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Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)

Primary Purpose

Cerebral Ischemia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device
Initial medical management (iMM)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Ischemia focused on measuring Immediate Mechanical Thrombectomy, Initial medical management, Large vessel occlusion, Efficacy, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years or older
  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:

  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 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

Sites / Locations

  • Providence Little Company of Mary Medical CenterRecruiting
  • Baptist Health Jacksonville FLRecruiting
  • University of Miami Miller School of MedicineRecruiting
  • Grady Health System (non-CRN)Recruiting
  • Rush University Medical Center: University NeurosurgeryRecruiting
  • Advocate Aurora HealthRecruiting
  • Indiana UniversityRecruiting
  • University of IowaRecruiting
  • Baptist Health Lexington
  • University of Massachusetts Medical CenterRecruiting
  • Michigan Medicine Comprehensive Stroke Center
  • Henry Ford Health SystemRecruiting
  • McLaren Health Care Corporation
  • Washington University School of MedicineRecruiting
  • JFK Neurosciences Center
  • Thomas Jefferson UniversityRecruiting
  • Albany Medical CenterRecruiting
  • University at Buffalo Neurosurgery/ Kaleida HealthRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • University of CincinnatiRecruiting
  • Cleveland ClinicRecruiting
  • Ohio State Wexner Medical CenterRecruiting
  • Riverside Medical Center, OhioHealth Research InstituteRecruiting
  • Oregon Health & Science University
  • Prisma Health-UpstateRecruiting
  • Semmes Murphey Foundation
  • Texas Tech University Health Sciences Center at El PasoRecruiting
  • VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen
  • University of Calgary and Foothills Medical CentreRecruiting
  • University of Alberta Hospital
  • University of Manitoba
  • London Health Sciences CentreRecruiting
  • Trillium Health Partners
  • The Ottawa Hospital Civic Campus
  • Sunnybrook Health Sciences Centre
  • Montreal Neurological Institute and Hospital
  • University of Saskatchewan
  • Universitätsklinikum Freiburg, Klinik für Neurologie
  • Universitäts Klinikum Heidelberg
  • Ludwig Maximilian University, Department of Neurology
  • Institute of Neuroradiology, University Hospital Frankfurt
  • Universitätsmedizin Göttingen
  • Klinikum Osnabrueck, Department of Neurology
  • Universitätsklinikum Essen
  • University Hospital Carl Gustav Carus Dresden Dresden, Department of Neurology
  • University Hospital Schleswig-Holstein, Campus Kiel
  • Gesundheit Nord Klinikum Bremen-Mitte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate mechanical thrombectomy(iMT)

Initial medical management (iMM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis).
The distribution of the modified Rankin Scale (mRS) is assessed by structured assessment. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Symptomatic intracranial hemorrhage (sICH) within 36 hours comparing the two treatment arms
Symptomatic intracranial hemorrhage (sICH) within 36 hours post treatment imaging scan, using SITS-MOST criteria, consisting of the presence of parenchymal hematoma type 2 (PH2) on neuroimaging associated with 4-point decline in NIHSS from baseline to 24 hours
Symptomatic intracerebral hemorrhage within 96 hours comparing the two treatment arms
Symptomatic intracerebral hemorrhage is defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage within 96 hours post-randomization, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 hour, or leading to death

Secondary Outcome Measures

Shift in distribution of the 90-day mRS with levels 5-6 combined (0;1;2;3;4;5-6) comparing the two treatment arms
The distribution of the 90-day modified Rankin Scale (mRS) with levels 5-6 combined (0;1;2;3;4;5-6) is assessed by structured assessment. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Number of patients with good outcome comparing the two treatment arms
Good outcome is defined by a score of 0-2 on the 90-day mRS. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Number of patients with excellent outcome comparing the two treatment arms arms
Excellent outcome is defined by a score 0-1 on the 90-day mRS. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Number of patients with early Neurologic Deterioration (END) comparing the two treatment arms
Early Neurologic Deterioration (END) is defined as an increase in NIHSS of ≥4 points. NIH Stroke Scale/Score (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
Health-related quality of life EQ-5D score comparing the two treatment arms
EQ-5D is a standardized instrument measuring health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number.
Infarct volume
Infarct volume is a direct measurement of one of the final pathologic steps leading to the clinical deficits caused by an ischemic stroke.Final infarct volume derived from MR imaging.
Self-reported mental and physical health PROMIS Global-10 score
Mental and physical health will be assessed using PROMIS Global-10. The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.Scores are converted to a T-Score metric.
Self-reported PROMIS Fatigue score
The PROMIS Fatigue assesses a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Each question has five response options ranging in value from one to five.To find the total raw score, values of the response to each question will be summed up. Total raw score will be transformed into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Number of patients with intracranial hemorrhages using the Heidelberg Bleeding definition comparing the two treatment arms
Intracranial hemorrhages will be defined using the Heidelberg Bleeding criteria.
Mortality rate within 90 days comparing the two treatment arms
Mortality rate will be calculated.
Instrumental Activities of Daily Living (IADL)
Instrumental Activities of Daily Living (IADLs) are activities related to independent living. The IADL scale covers eight functional domains: using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances. Participants are scored according to their highest level of functioning in categories, and summary score ranges from 0 (low function, dependent) to 8 (high function, independent).

Full Information

First Posted
November 15, 2019
Last Updated
September 6, 2023
Sponsor
Emory University
Collaborators
University of Calgary, University of Cincinnati, Heidelberg University, Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04167527
Brief Title
Endovascular Therapy for Low NIHSS Ischemic Strokes
Acronym
ENDOLOW
Official Title
Endovascular Therapy for Low NIHSS Ischemic Strokes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
University of Calgary, University of Cincinnati, Heidelberg University, Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia
Keywords
Immediate Mechanical Thrombectomy, Initial medical management, Large vessel occlusion, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate mechanical thrombectomy(iMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Initial medical management (iMM)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device
Other Intervention Name(s)
EmboTrap III
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Initial medical management (iMM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis).
Description
The distribution of the modified Rankin Scale (mRS) is assessed by structured assessment. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Time Frame
90-day
Title
Symptomatic intracranial hemorrhage (sICH) within 36 hours comparing the two treatment arms
Description
Symptomatic intracranial hemorrhage (sICH) within 36 hours post treatment imaging scan, using SITS-MOST criteria, consisting of the presence of parenchymal hematoma type 2 (PH2) on neuroimaging associated with 4-point decline in NIHSS from baseline to 24 hours
Time Frame
36 hours
Title
Symptomatic intracerebral hemorrhage within 96 hours comparing the two treatment arms
Description
Symptomatic intracerebral hemorrhage is defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage within 96 hours post-randomization, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 hour, or leading to death
Time Frame
96 hours
Secondary Outcome Measure Information:
Title
Shift in distribution of the 90-day mRS with levels 5-6 combined (0;1;2;3;4;5-6) comparing the two treatment arms
Description
The distribution of the 90-day modified Rankin Scale (mRS) with levels 5-6 combined (0;1;2;3;4;5-6) is assessed by structured assessment. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Time Frame
90-day
Title
Number of patients with good outcome comparing the two treatment arms
Description
Good outcome is defined by a score of 0-2 on the 90-day mRS. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Time Frame
90-day
Title
Number of patients with excellent outcome comparing the two treatment arms arms
Description
Excellent outcome is defined by a score 0-1 on the 90-day mRS. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Time Frame
90-day
Title
Number of patients with early Neurologic Deterioration (END) comparing the two treatment arms
Description
Early Neurologic Deterioration (END) is defined as an increase in NIHSS of ≥4 points. NIH Stroke Scale/Score (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
Time Frame
24 hours post randomization
Title
Health-related quality of life EQ-5D score comparing the two treatment arms
Description
EQ-5D is a standardized instrument measuring health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number.
Time Frame
90-day
Title
Infarct volume
Description
Infarct volume is a direct measurement of one of the final pathologic steps leading to the clinical deficits caused by an ischemic stroke.Final infarct volume derived from MR imaging.
Time Frame
24 hours post randomization
Title
Self-reported mental and physical health PROMIS Global-10 score
Description
Mental and physical health will be assessed using PROMIS Global-10. The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.Scores are converted to a T-Score metric.
Time Frame
90-day
Title
Self-reported PROMIS Fatigue score
Description
The PROMIS Fatigue assesses a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Each question has five response options ranging in value from one to five.To find the total raw score, values of the response to each question will be summed up. Total raw score will be transformed into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Time Frame
90-day
Title
Number of patients with intracranial hemorrhages using the Heidelberg Bleeding definition comparing the two treatment arms
Description
Intracranial hemorrhages will be defined using the Heidelberg Bleeding criteria.
Time Frame
90-day
Title
Mortality rate within 90 days comparing the two treatment arms
Description
Mortality rate will be calculated.
Time Frame
90-day
Title
Instrumental Activities of Daily Living (IADL)
Description
Instrumental Activities of Daily Living (IADLs) are activities related to independent living. The IADL scale covers eight functional domains: using the telephone, shopping, food preparation, housekeeping, laundry, transport, medication, and finances. Participants are scored according to their highest level of functioning in categories, and summary score ranges from 0 (low function, dependent) to 8 (high function, independent).
Time Frame
90-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of an objective neurological deficit Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.5 hours from symptom onset 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: 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 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 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%) or DWI if quantitative software tools are available (neither test is mandatory for study) 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 the local investigator High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of 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 an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Participation in another investigational treatment study in the previous 30 days Intubation and mechanical ventilation prior to study enrollment is medically indicated History of drug or alcohol use or dependence that, in the opinion of the site investigator, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Wright, MD
Phone
404-778-1709
Email
dwwrigh@emory.edu; endolow@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Hall, MS, RN, CEN
Phone
404-778-1585
Email
alex.hall@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul G Nogueira, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Little Company of Mary Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Tarpley, MD
Phone
310-303-5515
Email
jason.tarpley@providence.org
First Name & Middle Initial & Last Name & Degree
Audrey Hiemer
Phone
(714) 928-9334
Email
audrey.hiemer@providence.org
Facility Name
Baptist Health Jacksonville FL
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo A Hanel, MD
Phone
904-388-6518
Email
rhanel@lyerlyneuro.com
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Negar Asdaghi, MD
Phone
305-243-4453
Email
nasdaghi@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Iszet Campo-Bustillo
Phone
(305) 243-8018
Email
icampo@med.miami.edu
Facility Name
Grady Health System (non-CRN)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Wright, MD
Phone
404-778-1709
Email
dwwrigh@emory.edu
First Name & Middle Initial & Last Name & Degree
Shannon Doppelheuer, CCRC
Phone
404-778-1034
Email
sdoppelheuer@emory.edu
Facility Name
Rush University Medical Center: University Neurosurgery
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Chen, MD
Email
michael_chen@rush.edu
First Name & Middle Initial & Last Name & Degree
Corey Woods
Phone
(630) 631-1675
Email
Corey_J_Woods@rush.edu
Facility Name
Advocate Aurora Health
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demetrius Lopes, MD
Phone
847-723-2078
Email
Demetrius.Lopes@advocatehealth.com
First Name & Middle Initial & Last Name & Degree
Nicholas Armijo
Phone
(773) 317-9512
Email
nicholas.armijo@aah.org
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaustubh Limaye, MD
Phone
317-963-7505
Email
klimaye@iu.edu
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Samaniego, MD Ms
Phone
319-356-7428
Email
edgar-samaniego@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Heena Olalde
Phone
(319) 356-8362
Email
heena-olalde@uiowa.edu
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curtis Given, MD
Phone
859-277-6143
Email
Curtis.Given@bhsi.com
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajit S Puri, MD
Phone
508-334-8329
Email
Ajit.Puri@umassmemorial.org
First Name & Middle Initial & Last Name & Degree
Noelle Bodkin
Phone
(774) 441-8442
Email
Noelle.Bodkin@umassmed.edu
Facility Name
Michigan Medicine Comprehensive Stroke Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Withdrawn
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex B Chebl, MD
Phone
313-916-9107
Email
achebl1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Khalid Uddin
Phone
(313) 916-3955
Email
kuddin1@hfhs.org
Facility Name
McLaren Health Care Corporation
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Rayes, MD
Phone
586-493-8950
Email
Mahmoud.Rayes@mclaren.org
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arindam R Chatterjee, MD
Phone
314-362-5950
Email
chatterjee@wustl.edu
First Name & Middle Initial & Last Name & Degree
Robin Haverman
Phone
(314) 747-1624
Email
rlhaverman@wustl.edu
Facility Name
JFK Neurosciences Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddhart Mehta, MD
Phone
201-785-4999
Email
siddhart.mehta@hmhn.org
Facility Name
Thomas Jefferson University
City
Woodbury
State/Province
New Jersey
ZIP/Postal Code
08096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nabeel Herial, MD
Phone
215-955-7000
Email
nabeel.herial@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Chris Gahm
Phone
(609) 790-5184
Email
Christopher.Gahm@jefferson.edu
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Paul, MD
Phone
518-646-6761
Email
paula1@amc.edu
Facility Name
University at Buffalo Neurosurgery/ Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adnan Siddiqui, MD
Phone
716-218-1000
Email
asiddiqui@ubns.com
First Name & Middle Initial & Last Name & Degree
Jennifer Gay
Phone
716-440-4231
Email
jgay@ubns.com
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazem Shoira, MD
Phone
414-758-6127
Email
hazem.shoirah@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Sukaina Davdani
Phone
212-241-2524
Email
sukaina.davdani@mountsinai.org
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Grossman, MD
Phone
513-558-0156
Email
grossman@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Sadie Caldwell
Email
hamilts8@ucmail.uc.edu
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabor Toth, MD
Phone
216-444-0500
Email
tothg@ccf.org
First Name & Middle Initial & Last Name & Degree
Krysten Sackett-Fox
Phone
(216) 444-2946
Email
sacketk@ccf.org
Facility Name
Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivien Lee, MD
Phone
614-685-3031
Email
vivien.lee@hsumc.edu
First Name & Middle Initial & Last Name & Degree
Luke Herren
Phone
(614) 595-5142
Email
Luke.Herren@osumc.edu
Facility Name
Riverside Medical Center, OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Budzik, MD
Phone
614-566-1250
Email
rbudzik@riversiderad.com
First Name & Middle Initial & Last Name & Degree
Katy Groezinger
Phone
(614) 566-1255
Email
katy.groezinger@ohiohealth.com
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Withdrawn
Facility Name
Prisma Health-Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quill Turk, DO
Phone
864-797-7150
Email
Quill.Turk@prismahealth.org
Facility Name
Semmes Murphey Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Nickele, MD
Phone
901-522-7700
Email
cnickele@semmes-murphey.com
First Name & Middle Initial & Last Name & Degree
Amanda Nolte
Phone
(901)259-5316
Email
annolte@semmes-murphey.com
Facility Name
Texas Tech University Health Sciences Center at El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Maud, MD
Phone
915-215-5926
Email
alberto.maud@ttuhsc.edu
First Name & Middle Initial & Last Name & Degree
Israel Alba
Phone
(915)215-4616
Email
Israel.Alba@ttuhsc.edu
Facility Name
VHS-Harlingen Hospital Company dba Valley Baptist Medical Center-Harlingen
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ameer E Hassan, DO
Phone
973-303-8146
Email
Ameer.Hassan@valleybaptist.net ; ameerehassan@gmail.com
First Name & Middle Initial & Last Name & Degree
Pualani Smith
Phone
(956) 389-1776
Email
Pualani.Smith@valleybaptist.net
Facility Name
University of Calgary and Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 5A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Hill, MD
Phone
(403) 210-7786
Email
michael.hill@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Karla Ryckborst
Phone
(403) 660-3183
Email
Karla.Ryckborst@albertahealthservices.ca
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Buck, MD
Phone
(780) 709-4245
Email
bbuck@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Paige Fairall
Email
fairall@ualberta.ca
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD
Phone
(431) 373-4164
Email
shivajai1@gmail.com
First Name & Middle Initial & Last Name & Degree
Susan Alcock
Phone
(204)789-3996
Email
SALCOCK@hsc.mb.ca
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Mandzia, MD
Phone
(519) 685-8500
Ext
35406
Email
jennifer.mandzia@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Beth Beauchamp
Phone
(519) 685-8500
Ext
34136
Email
Beth.Beauchamp@lhsc.on.ca
Facility Name
Trillium Health Partners
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 2P7
Country
Canada
Individual Site Status
Withdrawn
Facility Name
The Ottawa Hospital Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dar Dowlatshahi, MD
Phone
(613) 798-5555
Ext
16449
Email
ddowlat@toh.ca
First Name & Middle Initial & Last Name & Degree
Zeinab Daham
Email
zdaham@ohri.ca
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Montreal Neurological Institute and Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grant Linnell, MD
Email
grant.linnell@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Erin Cole
Phone
(514) 398-7233
Email
erin.cole@mcgill.ca
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett Graham, MD
Phone
(306) 281-4075
Email
brett.r.graham@gmail.com
First Name & Middle Initial & Last Name & Degree
Simona Meier
Phone
(306) 978-8302
Email
simona.meier@usask.ca
Facility Name
Universitätsklinikum Freiburg, Klinik für Neurologie
City
Freiburg im Breisgau
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Bardutzky, MD
Phone
497 (612) 705-3090
Email
juergen.bardutzky@uniklinik-freiburg.de
Facility Name
Universitäts Klinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Nagel, MD
Phone
496 (221) 563-7186
Email
simon.nagel@med.uni-heidelberg.de
Facility Name
Ludwig Maximilian University, Department of Neurology
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Keller, MD
Phone
498 (944) 007-3692
Email
lars.kellert@med.uni-muenchen.de
Facility Name
Institute of Neuroradiology, University Hospital Frankfurt
City
Frankfurt Am Main
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Du Mesnil de Rochemont, MD
Phone
49 (696) 301-5462
Email
Richard.duMesnildeRochemont@kgu.de
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Riedel, MD
Phone
49 (551) 392-0696
Email
christian.riedel@med.uni-goettingen.de
Facility Name
Klinikum Osnabrueck, Department of Neurology
City
Osnabrück
State/Province
Niedersachsen
ZIP/Postal Code
49076
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Udo Krause, MD
Phone
49 (541) 405-6510
Email
lars.krause@klinikum-os.de
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Köhrmann
Phone
49 (201) 723-6502
Email
Martin.Koehrmann@uk-essen.de
Facility Name
University Hospital Carl Gustav Carus Dresden Dresden, Department of Neurology
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Pütz, MD
Phone
493 (514) 581-8443
Email
Volker.Puetz@uniklinikum-dresden.de
Facility Name
University Hospital Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olav Jansen, MD
Phone
494 (315) 001-6501
Email
olav.jansen@uksh.de
Facility Name
Gesundheit Nord Klinikum Bremen-Mitte
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Papanagiotou, MD
Phone
49 (421) 497-3625
Email
panagiotis-papanagiotou@klinikum-bremen-mitte.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article will be available after de-identification and in accordance with applicable laws and regulations. Other limited data sets may be provided as governed by ENDOLOW Publications SOP and in accordance with ICMJE.
IPD Sharing Time Frame
Data will become available beginning 1 year after publication of the primary analysis.
IPD Sharing Access Criteria
After primary analysis publication, site investigators will have the opportunity to contribute to secondary, tertiary and quaternary analysis of the data and publication. Additionally, after 1 year, non-investigator researchers may submit requests to the publications committee for additional analysis after providing a methodologically sound proposal. Proposals can be sent to ENDOLOW-CCC@emory.edu. Data Transfer Agreements may apply.
Citations:
PubMed Identifier
35122371
Citation
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.
Results Reference
derived

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Endovascular Therapy for Low NIHSS Ischemic Strokes

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