Analysis of Revascularization in Ischemic Stroke With EmboTrap (ARISEII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02488915
Recruitment Status : Recruiting
First Posted : July 2, 2015
Last Update Posted : September 27, 2016
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
Stroke Ischemia Device: EmboTrap® Revascularization Device

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : November 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2017

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

Primary Outcome Measures :
  1. The primary efficacy endpoint of the study is revascularization measured using modified Thrombolysis in Cerebrovascular Infarction (mTICI inclusive of the 2c rating). [ Time Frame: Baseline ]
    The primary efficacy endpoint of the study is revascularization measured using modified Thrombolysis in Cerebrovascular Infarction (mTICI inclusive of the 2c rating). 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.

  2. 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). [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Good clinical outcome [ Time Frame: 90(±14) days Post Procedure ]
    mRS score of ≤2

  2. Time to treat [ Time Frame: Baseline ]
    The time from groin puncture to visualization of the final angiographic result.

  3. All procedure-related mortality [ Time Frame: Day 7 ]
  4. All-cause Mortality [ Time Frame: 90(±14) days Post Procedure ]
  5. Serious Adverse Device Effect (SADE) [ Time Frame: 90(±14) days Post Procedure ]
  6. Procedure Related Serious Adverse Events (PRSAE) [ Time Frame: 90(±14) days Post Procedure ]
  7. Symptomatic ICH (sICH) [ Time Frame: 24 hours Post Procedure ]
  8. Neurological deterioration [ Time Frame: 24 hours Post Procedure ]
    An increase of 4 points or more on the NIHSS score

  9. Evidence of Infarction [ Time Frame: 24 hours post procedure ]
    Evidence of Infarction of a previously uninvolved vascular territory

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT02488915

Contact: Mairsíl Claffey
Contact: Ciara M McManus, BEng, MEng

United States, California
UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Sydney Starkman, MD         
Good Samaritan Hospital and Regional Medical Center Recruiting
San Jose, California, United States, 95124
Principal Investigator: Reza Malek, MD         
Principal Investigator: Arash Padidar, MD         
United States, Florida
University of Miami and Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Dileep Yavagal, MD         
United States, Georgia
Emory University School of Medicine, Recruiting
Atlanta, Georgia, United States, 30303
Principal Investigator: Raul Nogueira, MD         
United States, Ohio
Riverside Radiology and Interventional Associates Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Ronald Budzik, MD         
St Vincent Mercy Hospital Recruiting
Toledo, Ohio, United States, 43608
Principal Investigator: Sam Zaidat, MD         
United States, Oregon
OHSU Stroke Center Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Hormozd Bozorgchami, MD         
United States, Pennsylvania
UPMC Stroke Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Ashutosh Jadhav, MD         
United States, Tennessee
Tennessee Interventional and Imaging Associates Recruiting
Chattanooga, Tennessee, United States, 37403
Principal Investigator: Blaise Baxter, MD         
AZ Groeninge Recruiting
Kortrijk, Belgium
Principal Investigator: Tommy Andersson, MD         
UKSH Campus Kiel Recruiting
Kiel, Germany
Principal Investigator: Christian Riedel, MD         
Beaumont Hospital Recruiting
Dublin, Ireland
Principal Investigator: John Thornton, MD         
Sponsors and Collaborators
Neuravi Inc.
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.

Responsible Party: Neuravi Inc. Identifier: NCT02488915     History of Changes
Other Study ID Numbers: CIP002
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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