CERENOVUS Neurothrombectomy Devices Registry

NCT ID: NCT03685578

Last Updated: 2025-06-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-28

Study Completion Date

2025-02-20

Brief Summary

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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

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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.

Conditions

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Cerebral Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type DEVICE

EmboTrap® Revascularization Device

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Intervention Type DEVICE

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

CEREGLIDE 71 Intermediate Catheter

Intervention Type DEVICE

CEREGLIDE 71 Intermediate Catheter

Interventions

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EmboTrap® Revascularization Device

EmboTrap® Revascularization Device

Intervention Type DEVICE

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Intervention Type DEVICE

CEREGLIDE 71 Intermediate Catheter

CEREGLIDE 71 Intermediate Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18
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

1. 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
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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cerenovus, Part of DePuy Synthes Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Banner Desert Medical Center

Mesa, Arizona, United States

Site Status

Barrow Neurological Institute at St. Joseph's Hospital

Phoenix, Arizona, United States

Site Status

Vascular Neurology of Southern California: Dr. M. Asif Taqi

Thousand Oaks, California, United States

Site Status

Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Baptist Medical Center

Jacksonville, Florida, United States

Site Status

Lyerly Neurosurgery Baptist Health

Jacksonville, Florida, United States

Site Status

University of Miami- Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Advent Health Orlando

Orlando, Florida, United States

Site Status

Emory School of Medicine at Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

WellStar Health System

Marietta, Georgia, United States

Site Status

Norton Neurology Institute

Elizabethtown, Kentucky, United States

Site Status

Norton Healthcare

Louisville, Kentucky, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

Vanderbilt University Medical Center

Nashville, Missouri, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Jacobs Institute/UB Neurosurgery, Inc.

Buffalo, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio Health

Columbus, Ohio, United States

Site Status

Mercy Health St Vincent Medical Center

Toledo, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Geisinger Clinic

Danville, Pennsylvania, United States

Site Status

Geisinger

Danville, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

TNVI

Knoxville, Tennessee, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Semmes Murphey Foundation

Memphis, Tennessee, United States

Site Status

University of Texas Houston

Houston, Texas, United States

Site Status

Texas Stroke Institute

Plano, Texas, United States

Site Status

Az Groeninge

Kortrijk, , Belgium

Site Status

Hopital Roger Salengro - CHU Lille

Lille, , France

Site Status

Klinikum Dortmund gGmbH

Dortmund, , Germany

Site Status

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status

Universitaetsmedizin Mainz

Mainz, , Germany

Site Status

Radprax MVZ Nordrhein GmbH

Solingen, , Germany

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United States Belgium France Germany Israel Switzerland United Kingdom

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.

Reference Type DERIVED
PMID: 39559856 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38152640 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34645704 (View on PubMed)

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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