Trial Outcomes & Findings for Analysis of Revascularisation in Ischemic Stroke With EmboTrap (NCT NCT02190552)

NCT ID: NCT02190552

Last Updated: 2019-03-11

Results Overview

Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater. 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

• Recruitment status: TERMINATED
• Target enrollment: 40 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2019-03-11

Participant Flow

Participant milestones

Measure	EmboTrap® Revascularization Device The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	EmboTrap® Revascularization Device n=40 Participants The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device
Age, Continuous	64 years STANDARD_DEVIATION 14 • n=40 Participants
Sex: Female, Male Female	15 Participants n=40 Participants
Sex: Female, Male Male	25 Participants n=40 Participants
Region of Enrollment Sweden	14 participants n=40 Participants
Region of Enrollment Ireland	4 participants n=40 Participants
Region of Enrollment Germany	6 participants n=40 Participants
Region of Enrollment Spain	10 participants n=40 Participants
Region of Enrollment France	6 participants n=40 Participants
National Institutes of Health Stroke Scale (NIHSS) Score	15 units on a scale STANDARD_DEVIATION 5 • n=40 Participants
Body Mass Index (BMI)	27 kg/m^2 STANDARD_DEVIATION 4 • n=40 Participants

PRIMARY outcome

Timeframe: Day 1

Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.

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=39 Participants The EmboTrap® Revascularization Device is the investigational device
Proportion of Revascularisation Following the Use of the Neuravi Device.	28 Participants

SECONDARY outcome

Timeframe: Day 1

Defined as time from groin puncture to visualization of final angiographic result.

Outcome measures

Measure	EmboTrap® Revascularization Device n=39 Participants The EmboTrap® Revascularization Device is the investigational device
Time to Revascularization	76 minutes Standard Deviation 50

SECONDARY outcome

Timeframe: 7 and 90(±14) days post procedure

All procedure related mortality (i.e. directly traceable to a procedure related SAE).

Outcome measures

Measure	EmboTrap® Revascularization Device n=40 Participants The EmboTrap® Revascularization Device is the investigational device
Mortality Post Procedure Procedure-related Mortality at Day 7	0 Participants
Mortality Post Procedure All cause Mortality at Day 90	4 Participants

SECONDARY outcome

Timeframe: 24(-8/+12) hours Post Procedure

SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.

Outcome measures

Measure	EmboTrap® Revascularization Device n=40 Participants The EmboTrap® Revascularization Device is the investigational device
Serious Adverse Device Related Effects (SADE)	0 Participants

SECONDARY outcome

Timeframe: 24(-8/+12) hours Post Procedure

Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.

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=40 Participants The EmboTrap® Revascularization Device is the investigational device
Symptomatic ICH	0 Participants

SECONDARY outcome

Timeframe: 90(±14) days Post Procedure

Population: Data was not collected for all participants.

A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.

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=30 Participants The EmboTrap® Revascularization Device is the investigational device
Clinical Outcome at 90 Days	20 Participants

SECONDARY outcome

Timeframe: 24(-8/+12) hours Post Procedure

Population: Data were not collected

Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24(-8/+12) hours Post Procedure

Population: Data were not collected

Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.

Outcome measures

Outcome data not reported

Adverse Events

EmboTrap® Revascularization Device

Serious events: 9 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	EmboTrap® Revascularization Device n=40 participants at risk The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device
Infections and infestations Pneumonia	2.5% 1/40
Nervous system disorders Stroke in evolution	10.0% 4/40
Nervous system disorders Embolism	2.5% 1/40
Nervous system disorders Neurological Deterioration	2.5% 1/40
Nervous system disorders Occlusion	2.5% 1/40
Vascular disorders Pseudoaneurysm	2.5% 1/40
Vascular disorders Vessel perforation	5.0% 2/40

Other adverse events

Measure	EmboTrap® Revascularization Device n=40 participants at risk The EmboTrap® Revascularization Device is the investigational device EmboTrap® Revascularization Device
Cardiac disorders Atrial Fibrillation	5.0% 2/40
Cardiac disorders Bradycardia	7.5% 3/40
Cardiac disorders Other Cardiac disorders	5.0% 2/40
Infections and infestations Pneumonia	5.0% 2/40
Infections and infestations Urinary tract infection	12.5% 5/40
Investigations Blood potassium decreased	5.0% 2/40
Nervous system disorders Embolism	5.0% 2/40
Nervous system disorders Haemorrhagic transformation stroke	5.0% 2/40
Respiratory, thoracic and mediastinal disorders Other Respiratory disorders	5.0% 2/40
Vascular disorders Hypertension	5.0% 2/40

Additional Information

Mairsil Claffey

Neuravi Limited

Phone: 0035391394123

Email: mclaffey@neuravi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place