Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2000 participants
OBSERVATIONAL
2018-09-28
2025-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Mechanical Thrombectomy
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter
EmboTrap® Revascularization Device
EmboTrap® Revascularization Device
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CEREGLIDE 71 Intermediate Catheter
CEREGLIDE 71 Intermediate Catheter
Interventions
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EmboTrap® Revascularization Device
EmboTrap® Revascularization Device
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CEREGLIDE 71 Intermediate Catheter
CEREGLIDE 71 Intermediate Catheter
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Participants experiencing acute ischemic stroke with angiographic confirmation of intracranial vessel occlusion
4. 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
5. 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)
Exclusion Criteria
2. Confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication)
3. Use of multiple stent retrievers on the first pass
18 Years
ALL
No
Sponsors
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Cerenovus, Part of DePuy Synthes Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adnan Siddiqui, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Tommy Andersson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AZ Groeninge/ Karolinska University Hospital
Raul Nogueira, MD
Role: PRINCIPAL_INVESTIGATOR
UPMC Stroke Institute
Locations
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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
WellStar Health System
Marietta, Georgia, United States
Norton Neurology Institute
Elizabethtown, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
University of Massachusetts
Worcester, Massachusetts, United States
Vanderbilt University Medical Center
Nashville, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
Jacobs Institute/UB Neurosurgery, Inc.
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio Health
Columbus, Ohio, United States
Mercy Health St Vincent Medical Center
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Geisinger
Danville, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
TNVI
Knoxville, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Semmes Murphey Foundation
Memphis, Tennessee, United States
University of Texas Houston
Houston, Texas, United States
Texas Stroke Institute
Plano, Texas, United States
Az Groeninge
Kortrijk, , Belgium
Hopital Roger Salengro - CHU Lille
Lille, , France
Klinikum Dortmund gGmbH
Dortmund, , Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, , Germany
Universitaetsmedizin Mainz
Mainz, , Germany
Radprax MVZ Nordrhein GmbH
Solingen, , Germany
Hadassah Medical Center
Jerusalem, , Israel
Kantonsspital Aarau
Aarau, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, , Switzerland
Charing Cross Hospital
London, , United Kingdom
Countries
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References
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Nogueira RG, Andersson T, Haussen DC, Yoo AJ, Hanel RA, Zaidat OO, Hacke W, Jovin TG, Fiehler J, De Meyer SF, Brinjikji W, Doyle KM, Kallmes DF, Liebeskind DS, Virmani R, Kokoszka MA, Inoa V, Humphries W, Woodward KB, Jabbour PM, Francois O, Levy EI, Bozorgchami H, Boor S, Cohen JE, Dashti SR, Taqi MA, Budzik RF, Schirmer CM, Hussain MS, Estrade L, De Leacy RA, Puri AS, Chitale RV, Brekenfeld C, Siddiqui AH. EXCELLENT Registry: A Prospective, Multicenter, Global Registry of Endovascular Stroke Treatment With the EMBOTRAP Device. Stroke. 2024 Dec;55(12):2804-2814. doi: 10.1161/STROKEAHA.124.047324. Epub 2024 Nov 19.
Bilgin C, Dai D, Johnson C, Mereuta OM, Kallmes DF, Brinjikji W, Kadirvel R. Quality assessment of histopathological stainings on prolonged formalin fixed thrombus tissues retrieved by mechanical thrombectomy. Front Neurol. 2023 Dec 13;14:1223947. doi: 10.3389/fneur.2023.1223947. eCollection 2023.
Siddiqui AH, Waqas M, Brinjikji W, De Meyer SF, Doyle K, Fiehler J, Hacke W, Hanel RA, Jovin TG, Liebeskind DS, Yoo AJ, Zaidat OO, Andersson T, Nogueira RG. Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods. J Neurointerv Surg. 2022 Aug;14(8):783-787. doi: 10.1136/neurintsurg-2021-017671. Epub 2021 Oct 13.
Other Identifiers
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CNV_2017_02
Identifier Type: -
Identifier Source: org_study_id
NCT05591183
Identifier Type: -
Identifier Source: nct_alias
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