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Completed

NCT Number: NCT03685578

CERENOVUS Neurothrombectomy Devices Registry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Az Groeninge, Kortrijk, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

EmboTrap® Revascularization Device

Device

EmboTrap® Revascularization Device

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Device

CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

CEREGLIDE 71 Intermediate Catheter

Device

CEREGLIDE 71 Intermediate Catheter

Primary outcomes

  1. Successful Revascularization

    Time frame: 1 day

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

Secondary outcomes

  1. All-Cause Mortality

    Time frame: 90 days

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

  2. Symptomatic Intracerebral Hemorrhage

    Time frame: 24 hours

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

  3. Functional Independence

    Time frame: 90 days

    Modified Rankin Scale (mRS) of ≤ 2

    Modified Rankin Score (Scale from 0-6):

    0 - No symptoms.

    • - No significant disability. Able to carry out all usual activities, despite some symptoms.
    • - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    • - Moderate disability. Requires some help, but able to walk unassisted.
    • - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    • - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    • - Dead

Sponsors and collaborators

Lead sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Industry

Registry information

Official study title

Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

Acronym: EXCELLENT

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2018
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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