Acute Ischemic StrokeNCT06042335
A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
A study testing DAISe EZ in people with Acute Ischemic Stroke, run by MIVI Neuroscience, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- DAISe EZ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2.
- Diagnosis of acute ischemic stroke with study enrollment time < 24 hours from onset of symptoms.
- Disabling stroke defined as a baseline NIHSS > 6.
- Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M2.
- The following imaging criteria must also be met:
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- 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
- Signed informed consent from patient or legal representative
Who cannot join
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- Rapidly improving neurological deficits based on the investigator's clinical judgement.
- Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
- Severe contrast allergy or absolute contraindication to iodinated contrast.
- Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
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- Evidence of dissection in the carotid or target artery for treatment.
- Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
- Renal failure (on dialysis).
- Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
- Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
- Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
- Cerebral vasculitis or evidence of active systemic infection.
- Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
- Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- 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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Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- DAISe EZ
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAISe EZDevice
DAISe Thrombectomy System for mechanical thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| DAISe EZ | Experimental | Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration. Receives: Device: DAISe EZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful revascularization
Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.
Measured: 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.
Measured: 24 Hours [window: 12-36 hours] post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIVI Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042335
- Sponsor's protocol ID
- 102699
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
- ClinicalTrials.gov ID
- NCT06042335
- Acronym / sponsor ID
- 102699
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MIVI Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAISe EZ | Experimental | Device: DAISe EZMechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 years or older.
- Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2.
- Diagnosis of acute ischemic stroke with study enrollment time < 24 hours from onset of symptoms.
- Disabling stroke defined as a baseline NIHSS > 6.
- Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M2.
Key exclusion criteria (17 listed)
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- Rapidly improving neurological deficits based on the investigator's clinical judgement.
- Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
- Severe contrast allergy or absolute contraindication to iodinated contrast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAISe EZDAISe Thrombectomy System for mechanical thrombectomy | Device | DAISe EZ |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing DAISe EZ in people with Acute Ischemic Stroke, run by MIVI Neuroscience, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Cihlar (763-227-7833, scihlar@mivineuroscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful revascularization (time frame: Peri-Procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.