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Post Marketing Study to Evaluate the GCE Device (SPERO)

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ClinicalTrials.gov Identifier: NCT03898960
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Neuravi Limited

Brief Summary:
A post-market study evaluating the Geometric Clot Extractor (GCE) Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

Condition or disease Intervention/treatment
Cerebral Stroke Device: Geometric Clot Extractor (GCE) Device

Detailed Description:
The objective of this study is to assess the efficacy of the Geometric Clot Extractor (GCE) Device. The study will also report on clot characteristics and clinical outcomes.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Study to Evaluate NeuroThrombectomy Geometric Clot ExtractoR (GCE) Effectiveness in PatiEnts With Challenging Occlusions
Estimated Study Start Date : August 31, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Group/Cohort Intervention/treatment
Mechanical Thrombectomy
Geometric Clot Extractor (GCE) Device
Device: Geometric Clot Extractor (GCE) Device
Geometric Clot Extractor (GCE) Device




Primary Outcome Measures :
  1. Successful Revascularization without rescue [ Time Frame: Day 1 ]

    Measured using the mTICI scale. Successful revascularization is defined as an mTICI of greater than 2b.

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion; mTICI 1 = Penetration but not perfusion; mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized; mTICI 2c = Near-complete perfusion; mTICI 3 = Complete perfusion



Secondary Outcome Measures :
  1. Successful Revascularization [ Time Frame: Day 1 ]

    Measured using the mTICI scale. Successful revascularization is defined as an mTICI of greater than 2c.

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion; mTICI 1 = Penetration but not perfusion; mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized; mTICI 2c = Near-complete perfusion; mTICI 3 = Complete perfusion


  2. First study pass recanalization [ Time Frame: Day 1 ]

    Measured using the mTICI scale

    mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke: mTICI 0 = No perfusion; mTICI 1 = Penetration but not perfusion; mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized; mTICI 2c = Near-complete perfusion; mTICI 3 = Complete perfusion


  3. Embolization to a New Territory (ENT) [ Time Frame: Day 1 ]
    Occurrence of Embolization to a New Territory (ENT)

  4. Symptomatic Intracerebral Hemorrhage (sICH) [ Time Frame: 24 hours Post-procedure ]
    Symptomatic Intracerebral Hemorrhage (sICH) at 24 hours

  5. All-Cause Mortality [ Time Frame: 90 days Post-procedure ]
    90 Day All-Cause Mortality

  6. Modified Rankin Scale (mRS) of ≤ 2 [ Time Frame: 90 days Post-procedure ]

    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:

  • Age ≥ 18
  • The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form.
  • Patient has been treated with another Stent-retriever device without achieving successful reperfusion and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel or likely resulting from the same clot.
  • mRS 0-1 prior to this stroke.
  • The Geometric Clot Extractor is used to attempt revascularization.

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 (e.g. test, verbal communication).
  • Patients who had direct aspiration via syringe/mechanical pump prior to GCE.
  • All patients with severe hypertension on presentation (SBP > 220 mmHg and/or DBP > 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (SBP >185 mmHg and/ or DBP >110 mmHg).
  • Known cerebral vasculitis.
  • Known cancer with life expectancy less than 12 months.
  • Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
  • Intracranial stenosis that prevents access to the site of occlusion.
  • Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
  • Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
  • Evidence of dissection in the extra or intracranial cerebral arteries.
  • Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

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): NCT03898960


Contacts
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Contact: Maeve Holian +353 91 394 125 mholian1@its.jnj.com
Contact: Ciara McManus cmcmanu5@its.jnj.com

Locations
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Sweden
Karolinska Institute Not yet recruiting
Stockholm, Sweden
Contact: Patrick Brouwer, MD       patricius.brouwer@ki.se   
Principal Investigator: Patrick Brouwer, MD         
Sponsors and Collaborators
Neuravi Limited
Investigators
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Principal Investigator: Patrick Brouwer, MD Karolinska Institutet

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Responsible Party: Neuravi Limited
ClinicalTrials.gov Identifier: NCT03898960     History of Changes
Other Study ID Numbers: CNV_2018_01
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases