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A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE August 25, 2023
First Posted Date  ICMJE September 18, 2023
Last Update Posted Date March 13, 2024
Estimated Study Start Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2024)
  • Successful revascularization [ Time Frame: Peri-Procedural ]
    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 [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2023)
  • Successful revascularization [ Time Frame: Procedure ]
    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 [ Time Frame: 12-36 hours ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
Official Title  ICMJE A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE Device: DAISe EZ
DAISe Thrombectomy System for mechanical thrombectomy
Study Arms  ICMJE Experimental: DAISe EZ
Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
Intervention: Device: DAISe EZ
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2023)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Cihlar 763-227-7833 scihlar@mivineuroscience.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06042335
Other Study ID Numbers  ICMJE 102699
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party MIVI Neuroscience, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MIVI Neuroscience, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MIVI Neuroscience, Inc.
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP