A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
Study Details
Study Description
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 | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
|
Outcome Measures
Primary Outcome Measures
- Successful revascularization [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- 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.
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Diagnosis of acute ischemic stroke with study enrollment time < 24 hours from onset of symptoms.
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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.
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The following imaging criteria must also be met:
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For subjects 0-6hrs onset:
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MRI criterion: volume of diffusion restriction as assessed by automated core volume software ≤50 mL OR
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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.
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For subjects 6-24hrs onset:
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≤20mL ischemic core volume if age >80
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≤30mL ischemic core volume if age <80 and NIHSS 10-20
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The following imaging criteria must also be met:
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≤50mL ischemic core volume if age <80 and NIHSS >20 7. Signed informed consent from patient or legal representative
Exclusion Criteria:
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Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
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Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
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Rapidly improving neurological deficits based on the investigator's clinical judgement.
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Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
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Severe contrast allergy or absolute contraindication to iodinated contrast.
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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.
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Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
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Renal failure (on dialysis).
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Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
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Use of warfarin anticoagulation with International Normalized Ratio (INR) > 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
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Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
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Cerebral vasculitis or evidence of active systemic infection.
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Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
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Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
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A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- MIVI Neuroscience, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 102699