Status:
NOT_YET_RECRUITING
A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
Lead Sponsor:
MIVI Neuroscience, Inc.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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.
- 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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Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06042335
Start Date
July 1 2025
End Date
December 1 2025
Last Update
August 9 2024
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