Back to resultsAnalysis of Revascularization in Ischemic Stroke With EmboTrap (ARISEII)
Primary Purpose
Stroke, Ischemia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EmboTrap® Revascularization Device
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
- Aged between 18 years and 85 years (inclusive).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- NIHSS score ≥8 and ≤25.
- Pre-ictal mRS score of 0 or 1.
- The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
- Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
- 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.
- 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.
For strokes in the anterior circulation the following imaging criteria should also be met:
- MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
- CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.
- 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:
- Life expectancy likely less than 6 months.
- Females who are pregnant or breastfeeding.
- History of severe allergy to contrast medium.
- Known nickel allergy at time of treatment.
- Known current use of cocaine at time of treatment.
- Patient has suffered a stroke in the past 3 months.
- The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
- Subject participating in another study involving an investigational device or drug.
- Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) >3.0.
- Platelet count <50,000/μL.
- Glucose <50 mg/dL.
- Any known hemorrhagic or coagulation deficiency.
- Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
- 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.
- 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). .
- Known cerebral vasculitis.
- Rapidly improving neurological status.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Ongoing seizure due to stroke.
- Evidence of active systemic infection.
- Known cancer with metastases.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
- Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
- Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
Sites / Locations
- UCLA
- Good Samaritan Hospital and Regional Medical Center
- University of Miami and Jackson Memorial Hospital
- Emory University School of Medicine,
- Riverside Radiology and Interventional Associates
- St Vincent Mercy Hospital
- OHSU Stroke Center
- UPMC Stroke Center
- Tennessee Interventional and Imaging Associates
- AZ Groeninge
- UKSH Campus Kiel
- Beaumont Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EmboTrap® Revascularization Device
Arm Description
Mechanical Thrombectomy with EmboTrap
Outcomes
Primary Outcome Measures
Successful 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. 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
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
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
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
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.
Procedure Time
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
All Procedure-related Mortality
Any death that is deemed to have been caused by the study procedure.
All-cause Mortality
Any death that occurs within 90(±14) days post-procedure.
Occurrence of Serious Adverse Device Effects (SADE)
SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Occurrence of Procedure Related Serious Adverse Events (PRSAE)
PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.
Occurrence of Symptomatic Intracerebral Hemorrhage (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.
Occurrence of Neurological Deterioration
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.
Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
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)).
Time to Treat
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02488915
Brief Title
Analysis of Revascularization in Ischemic Stroke With EmboTrap
Acronym
ARISEII
Official Title
ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuravi Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemia
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EmboTrap® Revascularization Device
Arm Type
Experimental
Arm Description
Mechanical Thrombectomy with EmboTrap
Intervention Type
Device
Intervention Name(s)
EmboTrap® Revascularization Device
Other Intervention Name(s)
EmboTrap II
Primary Outcome Measure Information:
Title
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
Description
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
Time Frame
Post-treatment
Title
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
Description
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.
Time Frame
24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure
Secondary Outcome Measure Information:
Title
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
Description
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.
Time Frame
90(±14) days Post Procedure
Title
Procedure Time
Description
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
Time Frame
Post-treatment
Title
All Procedure-related Mortality
Description
Any death that is deemed to have been caused by the study procedure.
Time Frame
Day 7 post-procedure
Title
All-cause Mortality
Description
Any death that occurs within 90(±14) days post-procedure.
Time Frame
90(±14) days Post Procedure
Title
Occurrence of Serious Adverse Device Effects (SADE)
Description
SADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Time Frame
90(±14) days Post Procedure
Title
Occurrence of Procedure Related Serious Adverse Events (PRSAE)
Description
PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.
Time Frame
90(±14) days Post Procedure
Title
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)
Description
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.
Time Frame
24(-8/+12) hours post-procedure
Title
Occurrence of Neurological Deterioration
Description
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.
Time Frame
24(-8/+12) hours post-procedure
Title
Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
Description
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)).
Time Frame
24(-8/+12) hours post-procedure
Title
Time to Treat
Description
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
Time Frame
Post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient or the patient's legally authorized representative has signed and dated an Informed Consent Form.
Aged between 18 years and 85 years (inclusive).
A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
NIHSS score ≥8 and ≤25.
Pre-ictal mRS score of 0 or 1.
The interventionalist estimates that at least one deployment of the EmboTrap device can be completed within 8 hours from the onset of symptoms.
Patients for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA.
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.
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.
For strokes in the anterior circulation the following imaging criteria should also be met:
MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.
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:
Life expectancy likely less than 6 months.
Females who are pregnant or breastfeeding.
History of severe allergy to contrast medium.
Known nickel allergy at time of treatment.
Known current use of cocaine at time of treatment.
Patient has suffered a stroke in the past 3 months.
The patient presents with an NIHSS score <8 or >25 or is physician assessed as being in a clinically relevant uninterrupted coma.
Subject participating in another study involving an investigational device or drug.
Use of warfarin anticoagulation or any Novel Anticoagulant with International Normalized Ratio (INR) >3.0.
Platelet count <50,000/μL.
Glucose <50 mg/dL.
Any known hemorrhagic or coagulation deficiency.
Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.
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.
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). .
Known cerebral vasculitis.
Rapidly improving neurological status.
Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
Ongoing seizure due to stroke.
Evidence of active systemic infection.
Known cancer with metastases.
Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
Evidence of dissection in the extra or intracranial cerebral arteries.
Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Sam Zaidat, M.D.
Organizational Affiliation
St. Vincent Mercy Mercy Hospital, Toledo,Ohio, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Tommy Andersson, M.D.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Jeffery Saver, M.D.
Organizational Affiliation
UCLA, CA, USA.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof. Heinrich Mattle, M.D.
Organizational Affiliation
University of Berne, Berne, Switzerland.
Official's Role
Study Director
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Good Samaritan Hospital and Regional Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
University of Miami and Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine,
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Riverside Radiology and Interventional Associates
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
St Vincent Mercy Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
OHSU Stroke Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UPMC Stroke Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Tennessee Interventional and Imaging Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Facility Name
UKSH Campus Kiel
City
Kiel
Country
Germany
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34046008
Citation
Yoo AJ, Soomro J, Andersson T, Saver JL, Ribo M, Bozorgchami H, Dabus G, Liebeskind DS, Jadhav A, Mattle H, Zaidat OO. Benchmarking the Extent and Speed of Reperfusion: First Pass TICI 2c-3 Is a Preferred Endovascular Reperfusion Endpoint. Front Neurol. 2021 May 11;12:669934. doi: 10.3389/fneur.2021.669934. eCollection 2021.
Results Reference
derived
PubMed Identifier
29643261
Citation
Zaidat OO, Bozorgchami H, Ribo M, Saver JL, Mattle HP, Chapot R, Narata AP, Francois O, Jadhav AP, Grossberg JA, Riedel CH, Tomasello A, Clark WM, Nordmeyer H, Lin E, Nogueira RG, Yoo AJ, Jovin TG, Siddiqui AH, Bernard T, Claffey M, Andersson T. Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). Stroke. 2018 May;49(5):1107-1115. doi: 10.1161/STROKEAHA.117.020125. Epub 2018 Apr 11.
Results Reference
derived
Learn more about this trial
Analysis of Revascularization in Ischemic Stroke With EmboTrap
We'll reach out to this number within 24 hrs