CERENOVUS Neurothrombectomy Devices Registry

NCT03685578 | Completed FDA Device

• 1 other identifier: CNV_2017_02
• Study Type: observational
• Target: 2,000
• Locations: 7 countries
• Sites: 40

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.

Conditions

Cerebral Stroke

Keywords

Mechanical thrombectomy; EmboTrap; Embovac; Cereglide 71

Outcome Measures

Primary Outcomes (1)

• Successful Revascularization

  Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.

  1 day

Secondary Outcomes (3)

• All-Cause Mortality

  90 days

• Symptomatic Intracerebral Hemorrhage

  24 hours

• Functional Independence

  90 days

Study Arms (1)

Mechanical Thrombectomy

EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter

Device: EmboTrap® Revascularization Device; Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter; Device: CEREGLIDE 71 Intermediate Catheter

Interventions

EmboTrap® Revascularization Device DEVICE

EmboTrap® Revascularization Device

Mechanical Thrombectomy

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter DEVICE

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Mechanical Thrombectomy

CEREGLIDE 71 Intermediate Catheter DEVICE

CEREGLIDE 71 Intermediate Catheter

Mechanical Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Ischemic Stroke patients with angiographic confirmation of intracranial vessel occlusion.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

Study Sites (40)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Banner Desert Medical Center

Mesa, Arizona, 85202, United States

Location

Barrow Neurological Institute at St. Joseph's Hospital

Phoenix, Arizona, 85013, United States

Location

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

Thousand Oaks, California, 91360, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Lyerly Neurosurgery Baptist Health

Jacksonville, Florida, 32207, United States

Location

University of Miami- Jackson Memorial Hospital

Miami, Florida, 33133, United States

Location

Advent Health Orlando

Orlando, Florida, 32803, United States

Location

Emory School of Medicine at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

WellStar Health System

Marietta, Georgia, 30060, United States

Location

Norton Neurology Institute

Elizabethtown, Kentucky, 42701, United States

Location

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

University of Massachusetts

Worcester, Massachusetts, 30303, United States

Location

Vanderbilt University Medical Center

Nashville, Missouri, 37232, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Jacobs Institute/UB Neurosurgery, Inc.

Buffalo, New York, 14203, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health

Columbus, Ohio, 43214, United States

Location

Mercy Health St Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

TNVI

Knoxville, Tennessee, 37902, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

Location

University of Texas Houston

Houston, Texas, 77030, United States

Location

Texas Stroke Institute

Plano, Texas, 75075, United States

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

Hopital Roger Salengro - CHU Lille

Lille, 59037, France

Location

Klinikum Dortmund gGmbH

Dortmund, 44137, Germany

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitaetsmedizin Mainz

Mainz, 55101, Germany

Location

Radprax MVZ Nordrhein GmbH

Solingen, 42651, Germany

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, CH-1011, Switzerland

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39559856 DERIVED

• 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.

  PMID: 38152640 DERIVED

• 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.

  PMID: 34645704 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

thrombus / clot

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adnan Siddiqui, MD, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Tommy Andersson, MD, PhD

  AZ Groeninge/ Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Raul Nogueira, MD

  UPMC Stroke Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 26, 2018
• Study Start: September 28, 2018
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CH (2); US (30); FR (1); DE (4); IL (1); GB (1); BE (1)