ARISEII: Analysis of Revascularization in Ischemic Stroke With EmboTrap

• Sponsor: Neuravi Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02488915
• Collaborator: (none)
• Enrollment: 228
• Locations: 12
• Arm: 1
• Actual Duration (Months): 22
• Patients Per Site: 19
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Ischemia	Device: EmboTrap® Revascularization Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: N/A
• 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: Nov 1, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EmboTrap® Revascularization Device Mechanical Thrombectomy with EmboTrap	Device: EmboTrap® Revascularization Device; Other Names: EmboTrap II

Outcome Measures

Primary Outcome Measures

1. Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating) [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) [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 [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 [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 [Day 7 post-procedure]

   Any death that is deemed to have been caused by the study procedure.

4. All-cause Mortality [90(±14) days Post Procedure]

   Any death that occurs within 90(±14) days post-procedure.

5. Occurrence of Serious Adverse Device Effects (SADE) [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) [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) [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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:

11. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR

12. CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images, or, volume of significantly lowered CBV ≤50 mL.

13. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	Good Samaritan Hospital and Regional Medical Center	San Jose	California	United States	95124
3	University of Miami and Jackson Memorial Hospital	Miami	Florida	United States	33136
4	Emory University School of Medicine,	Atlanta	Georgia	United States	30303
5	Riverside Radiology and Interventional Associates	Columbus	Ohio	United States	43214
6	St Vincent Mercy Hospital	Toledo	Ohio	United States	43608
7	OHSU Stroke Center	Portland	Oregon	United States	97239
8	UPMC Stroke Center	Pittsburgh	Pennsylvania	United States	15213
9	Tennessee Interventional and Imaging Associates	Chattanooga	Tennessee	United States	37403
10	AZ Groeninge	Kortrijk		Belgium
11	UKSH Campus Kiel	Kiel		Germany
12	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)

• Study Protocol - Jun 28, 2016
• Statistical Analysis Plan - Sep 13, 2017

More Information

Publications

None provided.

• Responsible Party: Neuravi Inc.
• ClinicalTrials.gov Identifier: NCT02488915
• Other Study ID Numbers: CIP002
• First Posted: Jul 2, 2015
• Last Update Posted: Jul 13, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Ischemic Stroke; Ischemia

Study Results

Participant Flow

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Period Title: Overall Study
STARTED	228
COMPLETED	202
NOT COMPLETED	26

Baseline Characteristics

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Overall Participants	227
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68 (13)
Sex: Female, Male (Count of Participants)
Female	123 54.2%
Male	104 45.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%
Asian	3 1.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	15 6.6%
White	206 90.7%
More than one race	2 0.9%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Belgium	17 7.5%
United States	101 44.5%
Ireland	6 2.6%
Germany	43 18.9%
Spain	35 15.4%
France	23 10.1%
Switzerland	2 0.9%
National Institutes of Health Stroke Scale (NIHSS) Score (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	15.8 (5)
Pre-stroke Modified Rankin Scale (mRS) (Count of Participants)
mRS 0	177 78%
mRS 1	49 21.6%
mRS 2	1 0.4%
BMI (kg per square meter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg per square meter]	28.7 (6)
Medical History (Count of Participants)
Previous Stroke/TIA	43 18.9%
Previous MI/CAD	45 19.8%
Atrial Fibrillation	90 39.6%
Hypertension	155 68.3%
Diabetes Mellitus	45 19.8%
Dyslipidaemia	98 43.2%
Current or ex-smoker	56 24.7%
Most Proximal occlusion location (Count of Participants)
Internal carotid artery	10 4.4%
Internal carotid artery Terminus (L or T-type)	25 11%
M1 middle cerebral artery	126 55.5%
M2 middle cerebral artery	57 25.1%
Other	9 4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Analysis population includes all patients enrolled and treated with the EmboTrap device (N=227) irrespective of whether they met all incl/excl criteria.

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	182 80.2%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	12 5.3%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All patients enrolled and treated with the EmboTrap device for whom there is known data, including those who were subsequently treated with other therapies. However, outcome data excludes cases where the patient withdrew consent or was lost to follow up, with undefined/unknown scores.

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	217
Count of Participants [Participants]	146 64.3%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Median (Inter-Quartile Range) [minutes]	35

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	0 0%

6. Secondary Outcome

Title	All-cause Mortality
Description	Any death that occurs within 90(±14) days post-procedure.
Time Frame	90(±14) days Post Procedure

Outcome Measure Data

Analysis Population Description

Denominator excludes missing data. Participants who were Lost to Follow-up and Withdrew Consent were treated as missing data.

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	222
Count of Participants [Participants]	20 8.8%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	0 0%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	11 4.8%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	12 5.3%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Denominator exclude missing data. Participant who were not assessed for NIHSS at 24hrs and/or those who used rescue therapy at any time during the procedure were treated as missing data.

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	178
Count of Participants [Participants]	8 3.5%

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	34 15%

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Median (Inter-Quartile Range) [minutes]	24

13. Post-Hoc Outcome

Title	Proportion of Subjects With New Territory Embolisation
Description	Embolisation of any new territories was recorded directly post-treatment.
Time Frame	Post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Measure Participants	227
Count of Participants [Participants]	15 6.6%

Adverse Events

Time Frame	3 months
Arm/Group Title	EmboTrap® Revascularization Device
Arm/Group Description	Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
All Cause Mortality
	EmboTrap® Revascularization Device
	Affected / at Risk (%)	# Events
Total	20/227 (8.8%)
Serious Adverse Events
	EmboTrap® Revascularization Device
	Affected / at Risk (%)	# Events
Total	92/227 (40.5%)
Cardiac disorders
Myocardial infarction	3/227 (1.3%)	3
Atrial fibrillation	2/227 (0.9%)	2
Cardiac failure	2/227 (0.9%)	2
Cardiac arrest	1/227 (0.4%)	1
Sinus node dysfunction	1/227 (0.4%)	1
Bradycardia	1/227 (0.4%)	1
Angina unstable	1/227 (0.4%)	1
Tachycardia	1/227 (0.4%)	1
Cardiac failure acute	1/227 (0.4%)	1
Cardiovascular disorder	1/227 (0.4%)	1
Endocrine disorders
Hyperparathyroidism primary	1/227 (0.4%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	3/227 (1.3%)	3
Small intestinal obstruction	1/227 (0.4%)	1
Hiatus hernia	1/227 (0.4%)	1
Colitis ischaemic	1/227 (0.4%)	1
Haematemesis	1/227 (0.4%)	1
General disorders
Vessel puncture site thrombosis	1/227 (0.4%)	1
Vessel puncture site haemorrhage	1/227 (0.4%)	1
Hepatobiliary disorders
Cholecystitis	1/227 (0.4%)	1
Immune system disorders
Hypersensitivity	1/227 (0.4%)	1
Infections and infestations
Septic shock	4/227 (1.8%)	4
Urinary tract infection	3/227 (1.3%)	3
Pneumonia	3/227 (1.3%)	3
Sepsis	2/227 (0.9%)	2
Respiratory tract infection	2/227 (0.9%)	2
Infection	1/227 (0.4%)	1
Injury, poisoning and procedural complications
Vascular injury	1/227 (0.4%)	1
Splenic rupture	1/227 (0.4%)	1
Contusion	1/227 (0.4%)	1
Femoral neck fracture	1/227 (0.4%)	1
Investigations
International normalised ratio increased	1/227 (0.4%)	1
Metabolism and nutrition disorders
Malnutrition	1/227 (0.4%)	1
Diabetic ketoacidosis	1/227 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthritis	1/227 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm	1/227 (0.4%)	1
Nervous system disorders
Haemorrhagic transformation stroke	15/227 (6.6%)	15
Ischaemic stroke	14/227 (6.2%)	14
Brain oedema	7/227 (3.1%)	7
Neurological decompensation	5/227 (2.2%)	5
Subarachnoid haemorrhage	4/227 (1.8%)	4
Seizure	3/227 (1.3%)	3
Carotid artery stenosis	3/227 (1.3%)	3
Carotid artery dissection	2/227 (0.9%)	2
Metabolic encephalopathy	1/227 (0.4%)	1
Speech disorder	1/227 (0.4%)	1
Cerebral artery occlusion	1/227 (0.4%)	1
Disturbance in attention	1/227 (0.4%)	1
Psychiatric disorders
Depression	1/227 (0.4%)	1
Agitation	1/227 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration	4/227 (1.8%)	4
Respiratory failure	2/227 (0.9%)	2
Respiratory distress	2/227 (0.9%)	2
Bronchospasm	2/227 (0.9%)	2
Pulmonary embolism	1/227 (0.4%)	1
Hypoxia	1/227 (0.4%)	1
Pulmonary oedema	1/227 (0.4%)	1
Dyspnoea	1/227 (0.4%)	1
Pleural effusion	1/227 (0.4%)	1
Pneumothorax	1/227 (0.4%)	1
Acute respiratory failure	1/227 (0.4%)	1
Surgical and medical procedures
Coronary arterial stent insertion	2/227 (0.9%)	2
Vascular disorders
Vessel perforation	2/227 (0.9%)	2
Deep vein thrombosis	2/227 (0.9%)	2
Aortic stenosis	1/227 (0.4%)	1
Haemorrhage	1/227 (0.4%)	1
Other (Not Including Serious) Adverse Events
	EmboTrap® Revascularization Device
	Affected / at Risk (%)	# Events
Total	175/227 (77.1%)
Cardiac disorders
Atrial fibrillation	17/227 (7.5%)	18
Infections and infestations
Urinary tract infection	30/227 (13.2%)	30
Nervous system disorders
Haemorrhagic transformation stroke	54/227 (23.8%)	55
Subarachnoid haemorrhage	28/227 (12.3%)	28
Headache	19/227 (8.4%)	19
Cerebral vasoconstriction	12/227 (5.3%)	12
Vascular disorders
Hypotension	14/227 (6.2%)	14
Hypertension	12/227 (5.3%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.