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A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

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ClinicalTrials.gov Identifier: NCT06042335
Recruitment Status : Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
MIVI Neuroscience, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: DAISe EZ Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
Estimated Study Start Date : July 2024
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DAISe EZ
Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
 Device: DAISe EZ
DAISe Thrombectomy System for mechanical thrombectomy


Outcome Measures
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Primary Outcome Measures :
  1. Successful revascularization [ Time Frame: Peri-Procedural ]
    Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.

  2. Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure [ Time Frame: 24 Hours [window: 12-36 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.


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
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
      • ≤50mL ischemic core volume if age <80 and NIHSS >20
  7. Signed informed consent from patient or legal representative

Exclusion Criteria:

  1. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
  2. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  3. Rapidly improving neurological deficits based on the investigator's clinical judgement.
  4. Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
  5. Severe contrast allergy or absolute contraindication to iodinated contrast.
  6. Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
  7. Evidence of dissection in the carotid or target artery for treatment.
  8. Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
  9. Renal failure (on dialysis).
  10. Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
  11. Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
  12. Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
  13. Cerebral vasculitis or evidence of active systemic infection.
  14. Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
  15. Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

  16. A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

    -

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): NCT06042335


Contacts
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Contact: Stephanie Cihlar 763-227-7833 scihlar@mivineuroscience.com

Sponsors and Collaborators
MIVI Neuroscience, Inc.
More Information
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Responsible Party: MIVI Neuroscience, Inc.
ClinicalTrials.gov Identifier: NCT06042335    
Other Study ID Numbers: 102699
First Posted: September 18, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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