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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
228
UCLA
Los Angeles, California, United States
Good Samaritan Hospital and Regional Medical Center
San Jose, California, United States
University of Miami and Jackson Memorial Hospital
Miami, Florida, United States
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
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
Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)
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
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
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.
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Emory University School of Medicine,
Atlanta, Georgia, United States
Riverside Radiology and Interventional Associates
Columbus, Ohio, United States
St Vincent Mercy Hospital
Toledo, Ohio, United States
OHSU Stroke Center
Portland, Oregon, United States
UPMC Stroke Center
Pittsburgh, Pennsylvania, United States
Tennessee Interventional and Imaging Associates
Chattanooga, Tennessee, United States
AZ Groeninge
Kortrijk, Belgium
...and 2 more locations
Time frame: 90(±14) days Post Procedure
Procedure Time
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
All Procedure-related Mortality
Any death that is deemed to have been caused by the study procedure.
Time frame: Day 7 post-procedure
All-cause Mortality
Any death that occurs within 90(±14) days post-procedure.
Time frame: 90(±14) days Post Procedure
Occurrence of Serious Adverse Device Effects (SADE)
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
Occurrence of Procedure Related Serious Adverse Events (PRSAE)
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
Occurrence of Symptomatic Intracerebral Hemorrhage (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.
Time frame: 24(-8/+12) hours post-procedure
Occurrence of Neurological Deterioration
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
Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory
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
Time to Treat
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