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EmboTrap® Revascularization Device 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 : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Neuravi Limited

Study Description
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Brief Summary:
A post-market registry evaluating the EmboTrap® Revascularization Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

Condition or disease Intervention/treatment
Cerebral Stroke Device: EmboTrap® Revascularization Device

Detailed Description:
The objective of this study is to assess the efficacy of the EmboTrap® Revascularization Device in a real-world setting, as well as to explore correlations between patient comorbidities, clot characteristics, revascularization rates, and clinical outcomes.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 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, 2021
Estimated Study Completion Date : September 30, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Mechanical Thrombectomy
EmboTrap® Revascularization Device
 Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device


Outcome Measures
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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

Eligibility Criteria
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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 subject or the subject's legally authorized representative has signed and dated an Informed Consent Form
  3. Subjects experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion (LVO)
  4. A clinical decision has been made to use the EmboTrap® Revascularization Device independently and prior to enrollment in the research study.
  5. EmboTrap® Revascularization Device is the first attempted device/technique for mechanical thrombectomy for the intracranial occlusion in the subject.

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 (e.g. test, verbal communication)
Contacts and Locations
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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: Jennifer Alojipan 949-789-3964 JAlojipa@its.jnj.com

Locations
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United States, Florida
Lyerly Neurosurgery Baptist Health Recruiting
Jacksonville, Florida, United States, 32207
Principal Investigator: Ricardo Hanel         
United States, Kentucky
Norton Neurology Institute Recruiting
Elizabethtown, Kentucky, United States, 42701
Principal Investigator: Shervin Dashti         
United States, Pennsylvania
Geisinger Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Chelsie Derr       cmderr1@geisinger.edu   
Principal Investigator: Clemens Schirmer, MD, PhD         
Sponsors and Collaborators
Neuravi Limited
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
More Information
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Responsible Party: Neuravi Limited
ClinicalTrials.gov Identifier: NCT03685578    
Other Study ID Numbers: CNV_2017_02
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: July 2020

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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 Neuravi Limited:
Mechanical thrombectomy, EmboTrap
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases