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Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients (DAISE)

Primary Purpose

Stroke, Stroke, Ischemic, Stroke, Acute

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DAISe Device
Trevo or Solitaire
Sponsored by
MIVI Neuroscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring DAISE, thrombectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years and older
  • Pre-stroke independent functional status in activities of daily living with modified Rankin Score 0-1
  • Patient presenting with a disabling stroke device as NIHSS ≥6
  • Thrombolytic therapy (IV tPA), if indicated/administered, was initiated within 3 hours of onset/ last known well according to prescribed dosing.Endovascular treatment intended to be initiated (groin puncture) <24 hours from onset of symptoms or last known well time.
  • Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery.
  • The following image criteria should also be met:

For Subjects 0-6hrs onset:

  • MRI Criterion: volume of diffusion restriction as assessed by automated core volume software ≤50mL OR
  • CT Criterion: ASPECTS 6-10 on baseline CT or CTA-source images or, CPT as assessed by automated core volume software ≤50mL

For subjects 6-24hrs onset:

  • ≤20mL Ischemic core volume if age >80
  • ≤30mL Ischemic core volume if age <80 and NIHSS 10-20
  • ≤50mL Ischemic core volume if age <80 and NIHSS >20
  • Signed informed consent from patient or legal authorized representative.

Exclusion Criteria:

  • CT or MRI evidence of intracranial hemorrhage on presentation.
  • CT or MRI showing mass effect or intracranial tumor (meningioma >2cm in diameter)
  • CT or MRI evidence of carotid dissection or complete cervical carotid occlusion requiring a stent.
  • Previous stroke within the past 3 months.
  • Known arterial condition (proximal vessel stenosis or pre-existing stent) that would prevent the study devices from reaching the target vessel and/or preclude safe recovery of the study devices.
  • Pregnancy.
  • Severe contrast allergy or absolute contraindication to iodinated contrast.
  • Rapidly improving neurological status as determined by Investigator/Neurologist.
  • Renal failure/insufficiency with >3.0 mg/dL creatinine prior to procedure.
  • Severe, sustained hypertension resistant to treatment (SBP>185mmHg or DBP >110mmHg)
  • Use of warfarin anticoagulation with International Normalized Ratio (INR) >3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
  • For patients who have received a direct thrombin inhibitor within the last 48hrs; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
  • Platelet count < 50,000
  • Cerebral vasculitis or evidence of active systemic infection (including COVID-19)
  • Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
  • Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
  • Seizure due to stroke.
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  • Active participation in another study involving an investigational drug or device.
  • A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
  • Unwillingness to complete follow up visits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    DAISe Thrombectomy Device

    Stent Retriever

    Arm Description

    Mechanical Thrombectomy with DAISe

    Mechanical Thrombectomy with TREVO or Solitaire Device

    Outcomes

    Primary Outcome Measures

    Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
    Primary Safety Outcome: Symptomatic intracranial hemorrhage

    Secondary Outcome Measures

    mTICI 2b-3 after randomized modality
    mTICI 2b-3 after first attempt with randomized modality
    mTICI 2c-3 after randomized modality
    mTICI 2c-3 after the first attempt with randomized modality
    mTICI 2b-3 at end of the procedure
    mTICI 2c-3 at end of the procedure
    Procedure Time
    Time from groin puncture to first successful revascularization devices as mTICI 2b-3 flow (as long as final mTICI 2b-3 is achieved)
    Rates of procedure and/or device related serious adverse events
    Rate of all intracranial hemorrhage at 24hrs
    Rate of embolization to a new vascular territory (ENT) during procedure
    All-cause mortality at 90 days
    Neurologic/Stroke related mortality at 90 days
    Patient reported outcome assessment by PROMIS Global-10 at 90 days

    Full Information

    First Posted
    July 27, 2021
    Last Updated
    October 19, 2022
    Sponsor
    MIVI Neuroscience, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04991038
    Brief Title
    Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
    Acronym
    DAISE
    Official Title
    Prospective, Multi-center, Randomized Study to Compare the Safety and Efficacy of the DAISe Thrombectomy System and Stent Retrievers for Neurointervention in Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Withdrawn, considering alternative trial design
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Stroke, Ischemic, Stroke, Acute, Cerebrovascular Disorders, Cerebrovascular Accident
    Keywords
    DAISE, thrombectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DAISe Thrombectomy Device
    Arm Type
    Experimental
    Arm Description
    Mechanical Thrombectomy with DAISe
    Arm Title
    Stent Retriever
    Arm Type
    Active Comparator
    Arm Description
    Mechanical Thrombectomy with TREVO or Solitaire Device
    Intervention Type
    Device
    Intervention Name(s)
    DAISe Device
    Intervention Description
    Thrombectomy using the DAISE device
    Intervention Type
    Device
    Intervention Name(s)
    Trevo or Solitaire
    Intervention Description
    Thrombectomy using TREVO or Solitaire device
    Primary Outcome Measure Information:
    Title
    Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2
    Time Frame
    90 days
    Title
    Primary Safety Outcome: Symptomatic intracranial hemorrhage
    Time Frame
    24hrs post procedure
    Secondary Outcome Measure Information:
    Title
    mTICI 2b-3 after randomized modality
    Time Frame
    procedure after use of randomized device
    Title
    mTICI 2b-3 after first attempt with randomized modality
    Time Frame
    procedure after first attempt with randomized device
    Title
    mTICI 2c-3 after randomized modality
    Time Frame
    procedure after use of randomized device
    Title
    mTICI 2c-3 after the first attempt with randomized modality
    Time Frame
    procedure after first attempt with randomized device
    Title
    mTICI 2b-3 at end of the procedure
    Time Frame
    procedure after all interventions
    Title
    mTICI 2c-3 at end of the procedure
    Time Frame
    procedure after all interventions
    Title
    Procedure Time
    Description
    Time from groin puncture to first successful revascularization devices as mTICI 2b-3 flow (as long as final mTICI 2b-3 is achieved)
    Time Frame
    procedure
    Title
    Rates of procedure and/or device related serious adverse events
    Time Frame
    90 days
    Title
    Rate of all intracranial hemorrhage at 24hrs
    Time Frame
    24hrs
    Title
    Rate of embolization to a new vascular territory (ENT) during procedure
    Time Frame
    procedure
    Title
    All-cause mortality at 90 days
    Time Frame
    90 days
    Title
    Neurologic/Stroke related mortality at 90 days
    Time Frame
    90 days
    Title
    Patient reported outcome assessment by PROMIS Global-10 at 90 days
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years and older Pre-stroke independent functional status in activities of daily living with modified Rankin Score 0-1 Patient presenting with a disabling stroke device as NIHSS ≥6 Thrombolytic therapy (IV tPA), if indicated/administered, was initiated within 3 hours of onset/ last known well according to prescribed dosing.Endovascular treatment intended to be initiated (groin puncture) <24 hours from onset of symptoms or last known well time. Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery. The following image criteria should also be met: For Subjects 0-6hrs onset: MRI Criterion: volume of diffusion restriction as assessed by automated core volume software ≤50mL OR CT Criterion: ASPECTS 6-10 on baseline CT or CTA-source images or, CPT as assessed by automated core volume software ≤50mL For subjects 6-24hrs onset: ≤20mL Ischemic core volume if age >80 ≤30mL Ischemic core volume if age <80 and NIHSS 10-20 ≤50mL Ischemic core volume if age <80 and NIHSS >20 Signed informed consent from patient or legal authorized representative. Exclusion Criteria: CT or MRI evidence of intracranial hemorrhage on presentation. CT or MRI showing mass effect or intracranial tumor (meningioma >2cm in diameter) CT or MRI evidence of carotid dissection or complete cervical carotid occlusion requiring a stent. Previous stroke within the past 3 months. Known arterial condition (proximal vessel stenosis or pre-existing stent) that would prevent the study devices from reaching the target vessel and/or preclude safe recovery of the study devices. Pregnancy. Severe contrast allergy or absolute contraindication to iodinated contrast. Rapidly improving neurological status as determined by Investigator/Neurologist. Renal failure/insufficiency with >3.0 mg/dL creatinine prior to procedure. Severe, sustained hypertension resistant to treatment (SBP>185mmHg or DBP >110mmHg) Use of warfarin anticoagulation with International Normalized Ratio (INR) >3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency. For patients who have received a direct thrombin inhibitor within the last 48hrs; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure. Platelet count < 50,000 Cerebral vasculitis or evidence of active systemic infection (including COVID-19) Suspicion of aortic dissection, septic embolus, or bacterial endocarditis. Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation). Seizure due to stroke. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic. Active participation in another study involving an investigational drug or device. A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. Unwillingness to complete follow up visits.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adnan Siddiqui, MD, PhD
    Organizational Affiliation
    UB/Kaleida Health
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Brian Jankowitz, MD
    Organizational Affiliation
    U Penn Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Luvas Elijovich, MD
    Organizational Affiliation
    University of Tennessee Health Sciences Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients

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