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A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

Primary Purpose

Acute Ischemic Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DAISe EZ
Sponsored by
MIVI Neuroscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age 18 years or older. 2. Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2. 3. Diagnosis of acute ischemic stroke with study enrollment time < 24 hours from onset of symptoms. 4. Disabling stroke defined as a baseline NIHSS > 6. 5. Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M2. 6. The following imaging criteria must also be met: For subjects 0-6hrs onset: MRI criterion: volume of diffusion restriction as assessed by automated core volume software ≤50 mL OR CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images or, computed tomography perfusion (CPT) core as assessed by automated core volume software ≤50 mL. For subjects 6-24hrs onset: ≤20mL ischemic core volume if age >80 ≤30mL ischemic core volume if age <80 and NIHSS 10-20 The following imaging criteria must also be met: ≤50mL ischemic core volume if age <80 and NIHSS >20 7. Signed informed consent from patient or legal representative Exclusion Criteria: Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. Rapidly improving neurological deficits based on the investigator's clinical judgement. Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive. Severe contrast allergy or absolute contraindication to iodinated contrast. Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy. Evidence of dissection in the carotid or target artery for treatment. Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure. Renal failure (on dialysis). Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg). Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure. Cerebral vasculitis or evidence of active systemic infection. Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis. Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation). A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DAISe EZ

    Arm Description

    Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.

    Outcomes

    Primary Outcome Measures

    Successful revascularization
    Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.
    Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
    Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    September 11, 2023
    Sponsor
    MIVI Neuroscience, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06042335
    Brief Title
    A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
    Official Title
    A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MIVI Neuroscience, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 20 subjects. A maximum of 5 investigational centers in Australia will participate. Enrollment is expected to take about 4 months, subject participation will last about 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DAISe EZ
    Arm Type
    Experimental
    Arm Description
    Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
    Intervention Type
    Device
    Intervention Name(s)
    DAISe EZ
    Intervention Description
    DAISe Thrombectomy System for mechanical thrombectomy
    Primary Outcome Measure Information:
    Title
    Successful revascularization
    Description
    Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.
    Time Frame
    Procedure
    Title
    Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
    Description
    Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.
    Time Frame
    12-36 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Age 18 years or older. 2. Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2. 3. Diagnosis of acute ischemic stroke with study enrollment time < 24 hours from onset of symptoms. 4. Disabling stroke defined as a baseline NIHSS > 6. 5. Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M2. 6. The following imaging criteria must also be met: For subjects 0-6hrs onset: MRI criterion: volume of diffusion restriction as assessed by automated core volume software ≤50 mL OR CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images or, computed tomography perfusion (CPT) core as assessed by automated core volume software ≤50 mL. For subjects 6-24hrs onset: ≤20mL ischemic core volume if age >80 ≤30mL ischemic core volume if age <80 and NIHSS 10-20 The following imaging criteria must also be met: ≤50mL ischemic core volume if age <80 and NIHSS >20 7. Signed informed consent from patient or legal representative Exclusion Criteria: Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. Rapidly improving neurological deficits based on the investigator's clinical judgement. Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive. Severe contrast allergy or absolute contraindication to iodinated contrast. Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy. Evidence of dissection in the carotid or target artery for treatment. Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure. Renal failure (on dialysis). Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg). Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure. Cerebral vasculitis or evidence of active systemic infection. Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis. Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation). A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stephanie Cihlar
    Phone
    763-227-7833
    Email
    scihlar@mivineuroscience.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

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