CERENOVUS Neurothrombectomy Devices Registry (EXCELLENT)

May 29, 2025 updated by: Cerenovus, Part of DePuy Synthes Products, Inc.

Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Kortrijk, Belgium, 8500
        • Az Groeninge
  • France
      • Lille, France, 59037
        • Hopital Roger Salengro - CHU Lille
  • Germany
      • Dortmund, Germany, 44137
        • Klinikum Dortmund gGmbH
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg Eppendorf
      • Mainz, Germany, 55101
        • Universitaetsmedizin Mainz
      • Solingen, Germany, 42651
        • Radprax MVZ Nordrhein GmbH
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois (CHUV)
  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Desert Medical Center
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute at St. Joseph's Hospital
    • California
      • Thousand Oaks, California, United States, 91360
        • Vascular Neurology of Southern California: Dr. M. Asif Taqi
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Jacksonville, Florida, United States, 32207
        • Lyerly Neurosurgery Baptist Health
      • Miami, Florida, United States, 33133
        • University of Miami- Jackson Memorial Hospital
      • Orlando, Florida, United States, 32803
        • Advent Health Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory School of Medicine at Grady Memorial Hospital
      • Marietta, Georgia, United States, 30060
        • Wellstar Health System
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
        • Norton Neurology Institute
      • Louisville, Kentucky, United States, 40241
        • Norton Healthcare
    • Massachusetts
      • Worcester, Massachusetts, United States, 30303
        • University of Massachusetts
    • Missouri
      • Nashville, Missouri, United States, 37232
        • Vanderbilt University Medical Center
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • New York
      • Buffalo, New York, United States, 14203
        • Jacobs Institute/UB Neurosurgery, Inc.
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43214
        • Ohio Health
      • Toledo, Ohio, United States, 43608
        • Mercy Health St Vincent Medical Center
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Knoxville, Tennessee, United States, 37902
        • TNVI
      • Memphis, Tennessee, United States, 38120
        • Semmes Murphey Foundation
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Houston
      • Plano, Texas, United States, 75075
        • Texas Stroke Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mechanical Thrombectomy
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter
Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device
Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
Device: CEREGLIDE 71 Intermediate Catheter
CEREGLIDE 71 Intermediate Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Revascularization
Time Frame: 1 day
Assess cerebral revascularization using the modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 90 days
Summary of all mortality regardless of cause at 90 days post-procedure.
90 days
Symptomatic Intracerebral Hemorrhage
Time Frame: 24 hours
Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention
24 hours
Functional Independence
Time Frame: 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. - Dead
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2018

Primary Completion (Actual)

February 20, 2025

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNV_2017_02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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