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Cerebral StrokeEXCELLENTNCT03685578

CERENOVUS Neurothrombectomy Devices Registry

An observational study of Cerebral Stroke, run by Cerenovus, Part of DePuy Synthes Products, Inc. at 40 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebral Stroke
What is being tested?
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter and CEREGLIDE 71 Intermediate Catheter
Type of treatment
Medical device
How many people
2,000 participants
Where
40 sitesin 7 countries
Study dates
28 Sep 2018to 20 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

United States30 sites

  • Emory School of Medicine at Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Jacobs Institute/UB Neurosurgery, Inc.

    Buffalo, New York, 14203

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio Health

    Columbus, Ohio, 43214

  • Geisinger Clinic

    Danville, Pennsylvania, 17822

  • Geisinger

    Danville, Pennsylvania, 17822

  • Norton Neurology Institute

    Elizabethtown, Kentucky, 42701

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • University of Texas Houston

    Houston, Texas, 77030

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • Lyerly Neurosurgery Baptist Health

    Jacksonville, Florida, 32207

  • TNVI

    Knoxville, Tennessee, 37902

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Norton Healthcare

    Louisville, Kentucky, 40241

  • WellStar Health System

    Marietta, Georgia, 30060

  • Semmes Murphey Foundation

    Memphis, Tennessee, 38120

  • Banner Desert Medical Center

    Mesa, Arizona, 85202

  • University of Miami- Jackson Memorial Hospital

    Miami, Florida, 33133

  • Vanderbilt University Medical Center

    Nashville, Missouri, 37232

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Advent Health Orlando

    Orlando, Florida, 32803

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute at St. Joseph's Hospital

    Phoenix, Arizona, 85013

  • Texas Stroke Institute

    Plano, Texas, 75075

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Washington University in St. Louis

    St Louis, Missouri, 63110

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

    Thousand Oaks, California, 91360

  • Mercy Health St Vincent Medical Center

    Toledo, Ohio, 43608

  • University of Massachusetts

    Worcester, Massachusetts, 30303

Other trials in United States

Germany4 sites

  • Klinikum Dortmund gGmbH

    Dortmund, 44137

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Universitaetsmedizin Mainz

    Mainz, 55101

  • Radprax MVZ Nordrhein GmbH

    Solingen, 42651

Other trials in Germany

Switzerland2 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, CH-1011

Other trials in Switzerland

Belgium1 site

  • Az Groeninge

    Kortrijk, 8500

Other trials in Belgium

France1 site

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037

Other trials in France

Israel1 site

  • Hadassah Medical Center

    Jerusalem, 91120

Other trials in Israel

United Kingdom1 site

  • Charing Cross Hospital

    London, W6 8RF

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Cerebral Stroke
Being tested
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter
Keywords
Mechanical thrombectomy, EmboTrap, Embovac, Cereglide 71
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EmboTrap® Revascularization DeviceDevice

    EmboTrap® Revascularization Device

  • CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration CatheterDevice

    CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

  • CEREGLIDE 71 Intermediate CatheterDevice

    CEREGLIDE 71 Intermediate Catheter

Study groups in NCT03685578
Study groupRoleWhat they receive
Mechanical ThrombectomyEmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter, CEREGLIDE 71 Intermediate Catheter
Receives: Device: EmboTrap® Revascularization Device; Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter; Device: CEREGLIDE 71 Intermediate Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful Revascularization

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

    Measured: 1 day

Secondary outcomes (3)

  1. All-Cause Mortality

    Summary of all mortality regardless of cause at 90 days post-procedure.

    Measured: 90 days

  2. Symptomatic Intracerebral Hemorrhage

    Rate of intracranial hemorrhage as detected by brain imaging (CT/MR) measured 24 hours after intervention

    Measured: 24 hours

  3. Functional Independence

    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

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2018
  2. Study start28 Sep 2018
  3. Primary completion20 Feb 2025
  4. Study completion20 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03685578
Sponsor's protocol ID
CNV_2017_02
Acronym
EXCELLENT
Status last verified
May 2025
First submitted
7 Sep 2018
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 39559856

  • 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.

    PubMed 38152640

  • 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.

    PubMed 34645704

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Stroke, run by Cerenovus, Part of DePuy Synthes Products, Inc. at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Germany, Switzerland, Belgium, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Revascularization (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03685578, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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