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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. Identifier: NCT03685578
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : August 9, 2022
Information provided by (Responsible Party):
Neuravi Limited

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.

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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, 2023
Estimated Study Completion Date : September 30, 2023

Group/Cohort Intervention/treatment
Mechanical Thrombectomy
EmboTrap® Revascularization Device
Device: EmboTrap® Revascularization Device
EmboTrap® Revascularization Device

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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)

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 identifier (NCT number): NCT03685578

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Contact: Jennifer Alojipan 949-789-3964

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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   
Principal Investigator: Clemens Schirmer, MD, PhD         
Sponsors and Collaborators
Neuravi Limited
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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 Identifier (NCT Number):
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Responsible Party: Neuravi Limited Identifier: NCT03685578    
Other Study ID Numbers: CNV_2017_02
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022

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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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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases