Trial Outcomes & Findings for Analysis of Revascularization in Ischemic Stroke With EmboTrap (NCT NCT02488915)
NCT ID: NCT02488915
Last Updated: 2018-07-13
Results Overview
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
COMPLETED
NA
228 participants
Post-treatment
2018-07-13
Participant Flow
Participant milestones
| Measure |
EmboTrap® Revascularization Device
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Overall Study
STARTED
|
228
|
|
Overall Study
COMPLETED
|
202
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
EmboTrap® Revascularization Device
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Overall Study
Death
|
21
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
BMI not recorded per standard of care at all study sites
Baseline characteristics by cohort
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 13 • n=227 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=227 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=227 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=227 Participants
|
|
Race (NIH/OMB)
White
|
206 Participants
n=227 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=227 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=227 Participants
|
|
Region of Enrollment
Belgium
|
17 Participants
n=227 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=227 Participants
|
|
Region of Enrollment
Ireland
|
6 Participants
n=227 Participants
|
|
Region of Enrollment
Germany
|
43 Participants
n=227 Participants
|
|
Region of Enrollment
Spain
|
35 Participants
n=227 Participants
|
|
Region of Enrollment
France
|
23 Participants
n=227 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=227 Participants
|
|
National Institutes of Health Stroke Scale (NIHSS) Score
|
15.8 Scores on a scale
STANDARD_DEVIATION 5 • n=227 Participants
|
|
Pre-stroke Modified Rankin Scale (mRS)
mRS 0
|
177 Participants
n=227 Participants
|
|
Pre-stroke Modified Rankin Scale (mRS)
mRS 1
|
49 Participants
n=227 Participants
|
|
Pre-stroke Modified Rankin Scale (mRS)
mRS 2
|
1 Participants
n=227 Participants
|
|
BMI
|
28.7 kg per square meter
STANDARD_DEVIATION 6 • n=166 Participants • BMI not recorded per standard of care at all study sites
|
|
Medical History
Previous Stroke/TIA
|
43 Participants
n=227 Participants
|
|
Medical History
Previous MI/CAD
|
45 Participants
n=227 Participants
|
|
Medical History
Atrial Fibrillation
|
90 Participants
n=227 Participants
|
|
Medical History
Hypertension
|
155 Participants
n=227 Participants
|
|
Medical History
Diabetes Mellitus
|
45 Participants
n=227 Participants
|
|
Medical History
Dyslipidaemia
|
98 Participants
n=227 Participants
|
|
Medical History
Current or ex-smoker
|
56 Participants
n=227 Participants
|
|
Most Proximal occlusion location
Internal carotid artery
|
10 Participants
n=227 Participants
|
|
Most Proximal occlusion location
Internal carotid artery Terminus (L or T-type)
|
25 Participants
n=227 Participants
|
|
Most Proximal occlusion location
M1 middle cerebral artery
|
126 Participants
n=227 Participants
|
|
Most Proximal occlusion location
M2 middle cerebral artery
|
57 Participants
n=227 Participants
|
|
Most Proximal occlusion location
Other
|
9 Participants
n=227 Participants
|
PRIMARY outcome
Timeframe: Post-treatmentPopulation: Analysis population includes all patients enrolled and treated with the EmboTrap device (N=227) irrespective of whether they met all incl/excl criteria.
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
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
|
182 Participants
|
PRIMARY outcome
Timeframe: 24(-8/+12 hrs) hours post-procedure and 90(±14) days Post ProcedureThe 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.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
|
12 Participants
|
SECONDARY outcome
Timeframe: 90(±14) days Post ProcedurePopulation: 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.
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.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=217 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
|
146 Participants
|
SECONDARY outcome
Timeframe: Post-treatmentThe 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
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Procedure Time
|
35 minutes
Interval 24.0 to 58.0
|
SECONDARY outcome
Timeframe: Day 7 post-procedureAny death that is deemed to have been caused by the study procedure.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
All Procedure-related Mortality
|
0 Participants
|
SECONDARY outcome
Timeframe: 90(±14) days Post ProcedurePopulation: Denominator excludes missing data. Participants who were Lost to Follow-up and Withdrew Consent were treated as missing data.
Any death that occurs within 90(±14) days post-procedure.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=222 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
All-cause Mortality
|
20 Participants
|
SECONDARY outcome
Timeframe: 90(±14) days Post ProcedureSADE was categorized as any serious adverse event that was deemed to be caused by the study device.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Occurrence of Serious Adverse Device Effects (SADE)
|
0 Participants
|
SECONDARY outcome
Timeframe: 90(±14) days Post ProcedurePRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Occurrence of Procedure Related Serious Adverse Events (PRSAE)
|
11 Participants
|
SECONDARY outcome
Timeframe: 24(-8/+12) hours post-proceduresICH 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.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)
|
12 Participants
|
SECONDARY outcome
Timeframe: 24(-8/+12) hours post-procedurePopulation: 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.
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.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=178 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Occurrence of Neurological Deterioration
|
8 Participants
|
SECONDARY outcome
Timeframe: 24(-8/+12) hours post-procedureInfarction (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)).
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
|
34 Participants
|
SECONDARY outcome
Timeframe: Post-treatmentThe 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
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Time to Treat
|
24 minutes
Interval 13.0 to 45.0
|
POST_HOC outcome
Timeframe: Post-treatmentEmbolisation of any new territories was recorded directly post-treatment.
Outcome measures
| Measure |
EmboTrap® Revascularization Device
n=227 Participants
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Proportion of Subjects With New Territory Embolisation
|
15 Participants
|
Adverse Events
EmboTrap® Revascularization Device
Serious adverse events
| Measure |
EmboTrap® Revascularization Device
n=227 participants at risk
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.3%
3/227 • Number of events 3 • 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Cardiac disorders
Cardiac failure
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Cardiac disorders
Cardiac arrest
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Cardiac disorders
Sinus node dysfunction
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Cardiac disorders
Bradycardia
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Cardiac disorders
Angina unstable
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Cardiac disorders
Tachycardia
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiovascular disorder
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
3/227 • Number of events 3 • 3 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
General disorders
Vessel puncture site thrombosis
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
General disorders
Vessel puncture site haemorrhage
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Immune system disorders
Hypersensitivity
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Infections and infestations
Septic shock
|
1.8%
4/227 • Number of events 4 • 3 months
|
|
Infections and infestations
Urinary tract infection
|
1.3%
3/227 • Number of events 3 • 3 months
|
|
Infections and infestations
Pneumonia
|
1.3%
3/227 • Number of events 3 • 3 months
|
|
Infections and infestations
Sepsis
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Infections and infestations
Respiratory tract infection
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Infections and infestations
Infection
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Investigations
International normalised ratio increased
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
6.6%
15/227 • Number of events 15 • 3 months
|
|
Nervous system disorders
Ischaemic stroke
|
6.2%
14/227 • Number of events 14 • 3 months
|
|
Nervous system disorders
Brain oedema
|
3.1%
7/227 • Number of events 7 • 3 months
|
|
Nervous system disorders
Neurological decompensation
|
2.2%
5/227 • Number of events 5 • 3 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.8%
4/227 • Number of events 4 • 3 months
|
|
Nervous system disorders
Seizure
|
1.3%
3/227 • Number of events 3 • 3 months
|
|
Nervous system disorders
Carotid artery stenosis
|
1.3%
3/227 • Number of events 3 • 3 months
|
|
Nervous system disorders
Carotid artery dissection
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Nervous system disorders
Speech disorder
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Nervous system disorders
Disturbance in attention
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Depression
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Agitation
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.8%
4/227 • Number of events 4 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Vascular disorders
Vessel perforation
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.88%
2/227 • Number of events 2 • 3 months
|
|
Vascular disorders
Aortic stenosis
|
0.44%
1/227 • Number of events 1 • 3 months
|
|
Vascular disorders
Haemorrhage
|
0.44%
1/227 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
EmboTrap® Revascularization Device
n=227 participants at risk
Mechanical Thrombectomy with EmboTrap
EmboTrap® Revascularization Device
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
7.5%
17/227 • Number of events 18 • 3 months
|
|
Infections and infestations
Urinary tract infection
|
13.2%
30/227 • Number of events 30 • 3 months
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
23.8%
54/227 • Number of events 55 • 3 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
12.3%
28/227 • Number of events 28 • 3 months
|
|
Nervous system disorders
Headache
|
8.4%
19/227 • Number of events 19 • 3 months
|
|
Nervous system disorders
Cerebral vasoconstriction
|
5.3%
12/227 • Number of events 12 • 3 months
|
|
Vascular disorders
Hypotension
|
6.2%
14/227 • Number of events 14 • 3 months
|
|
Vascular disorders
Hypertension
|
5.3%
12/227 • Number of events 12 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place