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CERENOVUS Neurothrombectomy Devices Registry (EXCELLENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03685578
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : May 22, 2024
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

Brief 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.

Condition or disease Intervention/treatment
Cerebral Stroke Device: EmboTrap® Revascularization Device Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter

Detailed 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..

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : October 1, 2024

Group/Cohort Intervention/treatment
Mechanical Thrombectomy
EmboTrap® Revascularization Device, CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device

Device: CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter
CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter




Primary Outcome Measures :
  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 Outcome Measures :
  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.

    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


Biospecimen Retention:   Samples Without DNA
thrombus / clot


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute Ischemic Stroke patients with confirmed intracranial Large Vessel Occlusion.
Criteria

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 Large 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 Aspiration 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 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)

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685578


Contacts
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Contact: Erin O'Carroll- Godinez +1 949-433-9824 EOCarro3@its.jnj.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
Cerenovus, Part of DePuy Synthes Products, Inc.
Investigators
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Principal Investigator: Adnan Siddiqui, MD, PhD University at Buffalo
Principal Investigator: Tommy Andersson, MD, PhD AZ Groeninge/ Karolinska University Hospital
Principal Investigator: Raul G Nogueira, MD Grady Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
ClinicalTrials.gov Identifier: NCT03685578    
Obsolete Identifiers: NCT05591183
Other Study ID Numbers: CNV_2017_02
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: May 22, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cerenovus, Part of DePuy Synthes Products, Inc.:
Mechanical thrombectomy, EmboTrap, Embovac
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases