CERENOVUS Neurothrombectomy Devices Registry

Last updated: October 19, 2022
Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT05591183
CNV_2017_02
  • Ages > 18
  • All Genders

Study Summary

A post-market registry evaluating the EmboTrap® Revascularization Device and CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18
  2. The participant or the participant's legally authorized representative has signed anddated an Informed Consent Form. In the event that local regulations allow foralternative approaches of consent, these must be fulfilled as approved by the sponsorand site's ethics committee/regulatory authority (if applicable)
  3. Participants experiencing acute ischemic stroke with angiographic confirmation ofLarge Vessel Occlusion (LVO)
  4. A clinical decision has been made to use a CERENOVUS neurothrombectomy device (EmboTrap® Revascularization Device and/or Large Bore Catheter/EMBOVAC AspirationCatheter) independently and prior to enrollment in the research study
  5. A CERENOVUS neurothrombectomy device is the first attempted primary device/techniquefor mechanical thrombectomy for the intracranial occlusion in the participant. Thefollowing primary devices/techniques are eligible for this study: a) EmboTrap®Revascularization Device alone b) EmboTrap® Revascularization Device + co-aspirationwith the Large Bore Catheter/EMBOVAC Aspiration Catheter c) EmboTrap®Revascularization Device + co-aspiration with any other aspiration catheter d) LargeBore Catheter/EMBOVAC Aspiration Catheter alone (that is, direct aspiration with nostent retriever in the first attempted technique)

Exclusion

Exclusion Criteria:

  1. Currently participating in an investigational (drug, device, etc) clinical trial thatmay confound study endpoints. Patients in observational, natural history, and/orepidemiological studies not involving intervention are eligible
  2. Confirmation of positive pregnancy test according to site specific standard of care (example, test, verbal communication)

Study Design

Total Participants: 2000
Study Start date:
September 28, 2018
Estimated Completion Date:
October 01, 2024

Study Description

The objective of this study are to separately assess the effectiveness of the CERENOVUS neurothrombectomy devices (EmboTrap® Revascularization Device, and Large Bore Catheter/EMBOVAC Aspiration Catheter) in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes..

Connect with a study center

  • Az Groeninge

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037
    France

    Active - Recruiting

  • Klinikum Dortmund gGmbH

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitaetsmedizin Mainz

    Mainz, 55101
    Germany

    Active - Recruiting

  • Radprax MVZ Nordrhein GmbH

    Solingen, 42651
    Germany

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Kantonsspital Aarau

    Aarau, 5001
    Switzerland

    Active - Recruiting

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, CH-1011
    Switzerland

    Active - Recruiting

  • Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Banner Desert Medical Center

    Mesa, Arizona 85202
    United States

    Active - Recruiting

  • Barrow Neurological Institute at St. Joseph's Hospital

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

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

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Memorial Regional Hospital

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Baptist Medical Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Lyerly Neurosurgery Baptist Health

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • University of Miami- Jackson Memorial Hospital

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Advent Health Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Emory School of Medicine at Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • WellStar Health System

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Norton Neurology Institute

    Elizabethtown, Kentucky 42701
    United States

    Active - Recruiting

  • Norton Healthcare

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • University of Massachusetts

    Worcester, Massachusetts 30303
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Missouri 37232
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Jacobs Institute/UB Neurosurgery, Inc.

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio Health

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Mercy Health St Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97201
    United States

    Active - Recruiting

  • Geisinger

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • Geisinger Clinic

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • TNVI

    Knoxville, Tennessee 37902
    United States

    Active - Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Semmes Murphey Foundation

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • University of Texas Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Stroke Institute

    Plano, Texas 75075
    United States

    Active - Recruiting

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