Analysis of Revascularization in Ischemic Stroke With EmboTrap (ARISEII)

• 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: Neuravi Inc.
• Information provided by (Responsible Party): Neuravi Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Stroke; Ischemia
• Intervention: Device: EmboTrap® Revascularization Device
• Enrollment: 228

Participant Flow

Recruitment Details
Pre-assignment Details

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
Reason Not Completed
Death	21
Lost to Follow-up	4
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		EmboTrap® Revascularization Device
Arm/Group Description		Mechanical Thrombectomy with EmboTrap EmboTrap® Revascularization Device
Overall Number of Baseline Participants		227
Baseline Analysis Population Description		One subject enrolled was not treated with any thrombectomy device due to severe agitation.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	227 participants
		68 (13)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	227 participants
	Female	123 54.2%
	Male	104 45.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	227 participants
	American Indian or Alaska Native	1 0.4%
	Asian	3 1.3%
	Native Hawaiian or Other Pacific Islander	0 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 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
Belgium	Number Analyzed	227 participants
		17 7.5%
United States	Number Analyzed	227 participants
		101 44.5%
Ireland	Number Analyzed	227 participants
		6 2.6%
Germany	Number Analyzed	227 participants
		43 18.9%
Spain	Number Analyzed	227 participants
		35 15.4%
France	Number Analyzed	227 participants
		23 10.1%
Switzerland	Number Analyzed	227 participants
		2 0.9%
National Institutes of Health Stroke Scale (NIHSS) Score [1]; Mean (Standard Deviation); Unit of measure: Scores on a scale
	Number Analyzed	227 participants
		15.8 (5)
		[1] Measure Description: 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.
Pre-stroke Modified Rankin Scale (mRS) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	227 participants
	mRS 0	177 78.0%
	mRS 1	49 21.6%
	mRS 2	1 0.4%
		[1] Measure Description: 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.
BMI [1]; Mean (Standard Deviation); Unit of measure: Kg per square meter
	Number Analyzed	166 participants
		28.7 (6)
		[1] Measure Analysis Population Description: BMI not recorded per standard of care at all study sites
Medical History; Measure Type: Count of Participants; Unit of measure: Participants
Previous Stroke/TIA	Number Analyzed	227 participants
		43 18.9%
Previous MI/CAD	Number Analyzed	227 participants
		45 19.8%
Atrial Fibrillation	Number Analyzed	227 participants
		90 39.6%
Hypertension	Number Analyzed	227 participants
		155 68.3%
Diabetes Mellitus	Number Analyzed	227 participants
		45 19.8%
Dyslipidaemia	Number Analyzed	227 participants
		98 43.2%
Current or ex-smoker	Number Analyzed	227 participants
		56 24.7%
Most Proximal occlusion location; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	227 participants
	Internal carotid artery	10 4.4%
	Internal carotid artery Terminus (L or T-type)	25 11.0%
	M1 middle cerebral artery	126 55.5%
	M2 middle cerebral artery	57 25.1%
	Other	9 4.0%

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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	217
Measure Type: Count of Participants; Unit of Measure: Participants
	146 67.3%

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
Overall Number of Participants Analyzed	227
Median (Inter-Quartile Range); Unit of Measure: minutes
	35; (24 to 58)

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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: Participants
	0 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
Overall Number of Participants Analyzed	222
Measure Type: Count of Participants; Unit of Measure: Participants
	20 9.0%

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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: Participants
	0 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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: 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
Overall Number of Participants Analyzed	178
Measure Type: Count of Participants; Unit of Measure: Participants
	8 4.5%

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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: Participants
	34 15.0%

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
Overall Number of Participants Analyzed	227
Median (Inter-Quartile Range); Unit of Measure: minutes
	24; (13 to 45)

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
Overall Number of Participants Analyzed	227
Measure Type: Count of Participants; Unit of Measure: Participants
	15 6.6%

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	[Not Specified]
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 (%)
Total	20/227 (8.81%)
Serious Adverse Events
	EmboTrap® Revascularization Device
	Affected / at Risk (%)	# Events
Total	92/227 (40.53%)
Cardiac disorders
Myocardial infarction † 1	3/227 (1.32%)	3
Atrial fibrillation † 1	2/227 (0.88%)	2
Cardiac failure † 1	2/227 (0.88%)	2
Cardiac arrest † 1	1/227 (0.44%)	1
Sinus node dysfunction † 1	1/227 (0.44%)	1
Bradycardia † 1	1/227 (0.44%)	1
Angina unstable † 1	1/227 (0.44%)	1
Tachycardia † 1	1/227 (0.44%)	1
Cardiac failure acute † 1	1/227 (0.44%)	1
Cardiovascular disorder † 1	1/227 (0.44%)	1
Endocrine disorders
Hyperparathyroidism primary † 1	1/227 (0.44%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage † 1	3/227 (1.32%)	3
Small intestinal obstruction † 1	1/227 (0.44%)	1
Hiatus hernia † 1	1/227 (0.44%)	1
Colitis ischaemic † 1	1/227 (0.44%)	1
Haematemesis † 1	1/227 (0.44%)	1
General disorders
Vessel puncture site thrombosis † 1	1/227 (0.44%)	1
Vessel puncture site haemorrhage † 1	1/227 (0.44%)	1
Hepatobiliary disorders
Cholecystitis † 1	1/227 (0.44%)	1
Immune system disorders
Hypersensitivity † 1	1/227 (0.44%)	1
Infections and infestations
Septic shock † 1	4/227 (1.76%)	4
Urinary tract infection † 1	3/227 (1.32%)	3
Pneumonia † 1	3/227 (1.32%)	3
Sepsis † 1	2/227 (0.88%)	2
Respiratory tract infection † 1	2/227 (0.88%)	2
Infection † 1	1/227 (0.44%)	1
Injury, poisoning and procedural complications
Vascular injury † 1	1/227 (0.44%)	1
Splenic rupture † 1	1/227 (0.44%)	1
Contusion † 1	1/227 (0.44%)	1
Femoral neck fracture † 1	1/227 (0.44%)	1
Investigations
International normalised ratio increased † 1	1/227 (0.44%)	1
Metabolism and nutrition disorders
Malnutrition † 1	1/227 (0.44%)	1
Diabetic ketoacidosis † 1	1/227 (0.44%)	1
Musculoskeletal and connective tissue disorders
Arthritis † 1	1/227 (0.44%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm † 1	1/227 (0.44%)	1
Nervous system disorders
Haemorrhagic transformation stroke † 1	15/227 (6.61%)	15
Ischaemic stroke † 1	14/227 (6.17%)	14
Brain oedema † 1	7/227 (3.08%)	7
Neurological decompensation † 1	5/227 (2.20%)	5
Subarachnoid haemorrhage † 1	4/227 (1.76%)	4
Seizure † 1	3/227 (1.32%)	3
Carotid artery stenosis † 1	3/227 (1.32%)	3
Carotid artery dissection † 1	2/227 (0.88%)	2
Metabolic encephalopathy † 1	1/227 (0.44%)	1
Speech disorder † 1	1/227 (0.44%)	1
Cerebral artery occlusion † 1	1/227 (0.44%)	1
Disturbance in attention † 1	1/227 (0.44%)	1
Psychiatric disorders
Depression † 1	1/227 (0.44%)	1
Agitation † 1	1/227 (0.44%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration † 1	4/227 (1.76%)	4
Respiratory failure † 1	2/227 (0.88%)	2
Respiratory distress † 1	2/227 (0.88%)	2
Bronchospasm † 1	2/227 (0.88%)	2
Pulmonary embolism † 1	1/227 (0.44%)	1
Hypoxia † 1	1/227 (0.44%)	1
Pulmonary oedema † 1	1/227 (0.44%)	1
Dyspnoea † 1	1/227 (0.44%)	1
Pleural effusion † 1	1/227 (0.44%)	1
Pneumothorax † 1	1/227 (0.44%)	1
Acute respiratory failure † 1	1/227 (0.44%)	1
Surgical and medical procedures
Coronary arterial stent insertion † 1	2/227 (0.88%)	2
Vascular disorders
Vessel perforation † 1	2/227 (0.88%)	2
Deep vein thrombosis † 1	2/227 (0.88%)	2
Aortic stenosis † 1	1/227 (0.44%)	1
Haemorrhage † 1	1/227 (0.44%)	1
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	EmboTrap® Revascularization Device
	Affected / at Risk (%)	# Events
Total	175/227 (77.09%)
Cardiac disorders
Atrial fibrillation † 1	17/227 (7.49%)	18
Infections and infestations
Urinary tract infection † 1	30/227 (13.22%)	30
Nervous system disorders
Haemorrhagic transformation stroke † 1	54/227 (23.79%)	55
Subarachnoid haemorrhage † 1	28/227 (12.33%)	28
Headache † 1	19/227 (8.37%)	19
Cerebral vasoconstriction † 1	12/227 (5.29%)	12
Vascular disorders
Hypotension † 1	14/227 (6.17%)	14
Hypertension † 1	12/227 (5.29%)	12
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment

Limitations and 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.

Results Point of Contact

• Name/Title: Mairsíl Claffey
• Organization: Neuravi Ltd
• Phone: 0035391394123
• EMail: mclaffey@neuravi.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Neuravi Inc.
• ClinicalTrials.gov Identifier: NCT02488915
• Other Study ID Numbers: CIP002
• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Results First Submitted: May 17, 2018
• Results First Posted: July 13, 2018
• Last Update Posted: July 13, 2018