Analysis of Revascularization in Ischemic Stroke With EmboTrap

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

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

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

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

Time frame: 90(±14) days Post Procedure

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

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

Time frame: Day 7 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.

Time frame: 90(±14) days Post Procedure

Population: 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.

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

Population: 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.

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

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

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

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

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

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

Embolisation of any new territories was recorded directly post-treatment.

Time frame: Post-treatment