A post-market registry evaluating the EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC™ Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter in acute ischemic stroke patients with confirmed intracranial vessel occlusion.
The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, Large Bore Catheter/EMBOVAC Aspiration Catheter, and CEREGLIDE 71 Intermediate Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.
Study Type
OBSERVATIONAL
Enrollment
2,000
EmboTrap® Revascularization Device
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CEREGLIDE 71 Intermediate Catheter
Successful Revascularization
Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.
Time frame: 1 day
All-Cause Mortality
Summary of all mortality regardless of cause at 90 days post-procedure.
Time frame: 90 days
Symptomatic Intracerebral Hemorrhage
Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention
Time frame: 24 hours
Functional Independence
Modified Rankin Scale (mRS) of ≤ 2 Modified Rankin Score (Scale from 0-6): 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead
Time frame: 90 days
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Desert Medical Center
Mesa, Arizona, United States
Barrow Neurological Institute at St. Joseph's Hospital
Phoenix, Arizona, United States
Vascular Neurology of Southern California: Dr. M. Asif Taqi
Thousand Oaks, California, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Lyerly Neurosurgery Baptist Health
Jacksonville, Florida, United States
University of Miami- Jackson Memorial Hospital
Miami, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Emory School of Medicine at Grady Memorial Hospital
Atlanta, Georgia, United States
...and 30 more locations