Evaluation of the SONAS® Ultrasound Device for the Assessment of Bilateral Cerebral Perfusion in Subjects With Acute Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke, Acute
- Sponsor
- Burl Concepts, Inc.
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Assessment of Brain Perfusion
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this clinical investigation is to determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.
Detailed Description
This clinical investigation will assess the performance of the SONAS® device in subjects with acute stroke admitted to the emergency department or stroke unit within 24 hours of symptoms onset and confirmed occlusion of either the proximal middle, distal M1-segment cerebral arteries, or distal internal carotid arteries (including carotid-T occlusion) by cerebral magnetic resonance imaging (cMRI) or cerebral imaging computed tomography (cCT), including perfusion weighted (pw) imaging sequences, will be considered for the investigation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent obtained
- •Male or female subject ≥18 years
- •Clinical diagnosis of acute stroke (NIHSS score: ≥10)
- •Time of stroke symptoms onset: ≤24 hours
- •Confirmed occlusion of either the proximal middle cerebral artery (occlusion of the proximal, middle or distal M1-segment) or the distal internal carotid artery (including carotid-T occlusion) by cMRI or cCT (including perfusion weighted imaging sequences)
- •Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue®
- •Women of non-childbearing potential can be included in the clinical investigation, if confirmed by fulfilling at least 1 of the following criteria:
- •Postmenopausal (age-related amenorrhea for ≥12 consecutive months)
- •Documentation (based on medical records, medical examination, or medical history interview) of irreversible surgical sterilization by bilateral oophorectomy, bilateral salpingectomy, or hysterectomy
Exclusion Criteria
- •Subjects with known contraindications to the use of SonoVue®:
- •Subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and subjects with acute respiratory distress syndrome
- •SonoVue® must not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated
- •Known hypersensitivity to any of the following substances:
- •Sulphur hexafluoride
- •Macrogol 4000
- •Distearoylphosphatidylcholine
- •Dipalmitoylphosphatidylglycerol sodium
- •Palmitic acid
- •Pregnant women
Outcomes
Primary Outcomes
Assessment of Brain Perfusion
Time Frame: 24 hours
Measurement of the kinetic parameter time to peak (TTP) in the right and left-brain hemisphere during the SONAS® test
Comparison
Time Frame: 7 days
Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left-brain hemisphere
Assessment of Adverse Events
Time Frame: 72 hours
Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs Frequency, severity, relationship (to device, contrast agent, or procedure), and outcome of AEs