CERENOVUS Neurothrombectomy Devices Registry
- Conditions
- Cerebral Stroke
- Interventions
- Device: EmboTrap® Revascularization DeviceDevice: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration CatheterDevice: CEREGLIDE 71 Intermediate Catheter
- Registration Number
- NCT03685578
- Lead Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Age ≥ 18
- The participant or the participant's legally authorized representative has signed and dated an Informed Consent Form. In the event that local regulations allow for alternative approaches of consent, these must be fulfilled as approved by the sponsor and site's ethics committee/regulatory authority (if applicable)
- Participants experiencing acute ischemic stroke with angiographic confirmation of intracranial vessel occlusion
- A clinical decision has been made to use a CERENOVUS neurothrombectomy device (EmboTrap® Revascularization Device, Large Bore Catheter/ EMBOVAC Aspiration Catheter, or CEREGLIDE 71 Intermediate Catheter) independently and prior to enrollment in the research study
- A CERENOVUS neurothrombectomy device is the first attempted primary device/technique for mechanical thrombectomy for the intracranial occlusion in the participant. The following primary devices/techniques are eligible for this study: a) EmboTrap® Revascularization Device alone b) EmboTrap® Revascularization Device + co-aspiration with the Large Bore Catheter/EMBOVAC Aspiration Catheter or CEREGLIDE 71 Intermediate Catheter c) EmboTrap® Revascularization Device + co-aspiration with any other aspiration catheter d) Large Bore Catheter/EMBOVAC Aspiration Catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique) e) CEREGLIDE 71 Intermediate Catheter alone (that is, direct aspiration with no stent retriever in the first attempted technique)
- Currently participating in an investigational (drug, device, etc) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- Confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication)
- Use of multiple stent retrievers on the first pass
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mechanical Thrombectomy CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter Mechanical Thrombectomy EmboTrap® Revascularization Device EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter Mechanical Thrombectomy CEREGLIDE 71 Intermediate Catheter EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter
- Primary Outcome Measures
Name Time Method Successful Revascularization 1 day Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.
- Secondary Outcome Measures
Name Time Method Functional Independence 90 days 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. - DeadSymptomatic Intracerebral Hemorrhage 24 hours Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention
All-Cause Mortality 90 days Summary of all mortality regardless of cause at 90 days post-procedure.
Trial Locations
- Locations (40)
Barrow Neurological Institute at St. Joseph's Hospital
🇺🇸Phoenix, Arizona, United States
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Vascular Neurology of Southern California: Dr. M. Asif Taqi
🇺🇸Thousand Oaks, California, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Emory School of Medicine at Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
University of Miami- Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Norton Neurology Institute
🇺🇸Elizabethtown, Kentucky, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Jacobs Institute/UB Neurosurgery, Inc.
🇺🇸Buffalo, New York, United States
Lyerly Neurosurgery Baptist Health
🇺🇸Jacksonville, Florida, United States
WellStar Health System
🇺🇸Marietta, Georgia, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Missouri, United States
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Switzerland
Ohio Health
🇺🇸Columbus, Ohio, United States
TNVI
🇺🇸Knoxville, Tennessee, United States
Texas Stroke Institute
🇺🇸Plano, Texas, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Universitaetsmedizin Mainz
🇩🇪Mainz, Germany
Hopital Roger Salengro - CHU Lille
🇫🇷Lille, France
Radprax MVZ Nordrhein GmbH
🇩🇪Solingen, Germany
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
University of Texas Houston
🇺🇸Houston, Texas, United States
Mercy Health St Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
Geisinger
🇺🇸Danville, Pennsylvania, United States
Universitaetsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Az Groeninge
🇧🇪Kortrijk, Belgium
Klinikum Dortmund gGmbH
🇩🇪Dortmund, Germany
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Semmes Murphey Foundation
🇺🇸Memphis, Tennessee, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Charing Cross Hospital
🇬🇧London, United Kingdom