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NCT06042335 | NOT YET RECRUITING | Acute Ischemic Stroke

A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
Sponsor:

MIVI Neuroscience, Inc.

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

Acute Ischemic Stroke

Intervention/treatment

DAISe EZ

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
        • -
A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

Location Details

NCT06042335

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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