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Analysis of Revascularization in Ischemic Stroke With EmboTrap (ARISEII)

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ClinicalTrials.gov Identifier: NCT02488915
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Neuravi Inc.

Brief Summary:
The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.

Condition or disease Intervention/treatment Phase
Stroke Ischemia Device: EmboTrap® Revascularization Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study
Actual Study Start Date : November 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: EmboTrap® Revascularization Device
Mechanical Thrombectomy with EmboTrap
Device: EmboTrap® Revascularization Device
Other Name: EmboTrap II




Primary Outcome Measures :
  1. Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating) [ Time Frame: Post-treatment ]

    Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.)

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:

    mTICI 0 = No perfusion

    mTICI 1 = Penetration but not perfusion

    mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized

    mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized

    mTICI 2c = Near-complete perfusion

    mTICI 3 = Complete perfusion


  2. Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE) [ Time Frame: 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure ]

    The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH).

    sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device.



Secondary Outcome Measures :
  1. Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2 [ Time Frame: 90(±14) days Post Procedure ]

    Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure.

    mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6:

    mRS 0 = No symptoms.

    mRS 1 = No significant disability.

    mRS 2 = Slight disability.

    mRS 3 = Moderate disability.

    mRS 4 = Moderately severe disability.

    mRS 5 = Severe disability.

    mRS 6 = Dead.


  2. Procedure Time [ Time Frame: Post-treatment ]

    The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:

    mTICI 0 = No perfusion

    mTICI 1 = Penetration but not perfusion

    mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized

    mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized

    mTICI 2c = Near-complete perfusion

    mTICI 3 = Complete perfusion


  3. All Procedure-related Mortality [ Time Frame: Day 7 post-procedure ]
    Any death that is deemed to have been caused by the study procedure.

  4. All-cause Mortality [ Time Frame: 90(±14) days Post Procedure ]
    Any death that occurs within 90(±14) days post-procedure.

  5. Occurrence of Serious Adverse Device Effects (SADE) [ Time Frame: 90(±14) days Post Procedure ]
    SADE was categorized as any serious adverse event that was deemed to be caused by the study device.

  6. Occurrence of Procedure Related Serious Adverse Events (PRSAE) [ Time Frame: 90(±14) days Post Procedure ]
    PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.

  7. Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) [ Time Frame: 24(-8/+12) hours post-procedure ]
    sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention.

  8. Occurrence of Neurological Deterioration [ Time Frame: 24(-8/+12) hours post-procedure ]
    An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The 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. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.

  9. Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory [ Time Frame: 24(-8/+12) hours post-procedure ]
    Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)).

  10. Time to Treat [ Time Frame: Post-treatment ]

    The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:

    mTICI 0 = No perfusion

    mTICI 1 = Penetration but not perfusion

    mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized

    mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized

    mTICI 2c = Near-complete perfusion

    mTICI 3 = Complete perfusion




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
  2. Aged between 18 years and 85 years (inclusive).
  3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
  4. NIHSS score ≥8 and ≤25.
  5. Pre-ictal mRS score of 0 or 1.
  6. The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
  7. Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
  8. IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as the last time when the patient was witnessed to be at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.
  9. Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1 or M2 MCA, VA, or BA with mTICI flow of 0 - 1.
  10. For strokes in the anterior circulation the following imaging criteria should also be met:

    1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
    2. CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.
  11. The patient is indicated for neurothrombectomy treatment by the interventionalist and it is confirmed by diagnostic angiography that the device will be able to reach the target lesion proximally.

Exclusion Criteria:

  1. Life expectancy likely less than 6 months.
  2. Females who are pregnant or breastfeeding.
  3. History of severe allergy to contrast medium.
  4. Known nickel allergy at time of treatment.
  5. Known current use of cocaine at time of treatment.
  6. Patient has suffered a stroke in the past 3 months.
  7. The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
  8. Subject participating in another study involving an investigational device or drug.
  9. Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) >3.0.
  10. Platelet count <50,000/μL.
  11. Glucose <50 mg/dL.
  12. Any known hemorrhagic or coagulation deficiency.
  13. Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
  14. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
  15. All patients with severe hypertension on presentation (SBP> 220mmHg and/or DBP>120mmHg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous therapy (SBP >185mmHg and/or DBP>110mmHg). .
  16. Known cerebral vasculitis.
  17. Rapidly improving neurological status.
  18. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  19. Ongoing seizure due to stroke.
  20. Evidence of active systemic infection.
  21. Known cancer with metastases.
  22. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
  23. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
  24. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
  25. Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
  26. Evidence of dissection in the extra or intracranial cerebral arteries.
  27. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488915


Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Good Samaritan Hospital and Regional Medical Center
San Jose, California, United States, 95124
United States, Florida
University of Miami and Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Georgia
Emory University School of Medicine,
Atlanta, Georgia, United States, 30303
United States, Ohio
Riverside Radiology and Interventional Associates
Columbus, Ohio, United States, 43214
St Vincent Mercy Hospital
Toledo, Ohio, United States, 43608
United States, Oregon
OHSU Stroke Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
UPMC Stroke Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Tennessee Interventional and Imaging Associates
Chattanooga, Tennessee, United States, 37403
Belgium
AZ Groeninge
Kortrijk, Belgium
Germany
UKSH Campus Kiel
Kiel, Germany
Ireland
Beaumont Hospital
Dublin, Ireland
Sponsors and Collaborators
Neuravi Inc.
Investigators
Principal Investigator: Prof. Sam Zaidat, M.D. St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA
Principal Investigator: Prof. Tommy Andersson, M.D. Karolinska Institutet
Study Director: Prof. Jeffery Saver, M.D. UCLA, CA, USA.
Study Director: Prof. Heinrich Mattle, M.D. University of Berne, Berne, Switzerland.
  Study Documents (Full-Text)

Documents provided by Neuravi Inc.:
Study Protocol  [PDF] June 28, 2016
Statistical Analysis Plan  [PDF] September 13, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neuravi Inc.
ClinicalTrials.gov Identifier: NCT02488915     History of Changes
Other Study ID Numbers: CIP002
First Posted: July 2, 2015    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neuravi Inc.:
Brain
Brain Clot
Brain Diseases
Brain Infarction
Cerebral Ischemia
Cerebrovascular Disorders
EmboTrap® Revascularization Device
EmboTrap
Ischemia
Ischemic
Ischemic Stroke
Mechanical Thrombectomy
Neurovascular Intervention
Revascularization
Stent Retriever
Stroke
Vascular Diseases
Neuravi

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes