A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: DAISe EZ

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Cihlar; Phone Number: 763-227-7833; Email: scihlar@mivineuroscience.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful revascularization	Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.	Peri-Procedural
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.	24 Hours [window: 12-36 hours] post procedure

Collaborators and Investigators

• Sponsor: MIVI Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 102699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes