E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute large vessel occlusion (LVO) stroke (NIHSS score: ≥ 10) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042244 |
E.1.2 | Term | Stroke |
E.1.2 | System Organ Class | 100000004852 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent obtained 2. Male or female aged at least 18 3. Clinical diagnosis of acute stroke (NIHSS score: ≥10) 4. Time of stroke symptoms onset: ≤24 hours 5. 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) 6. Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue® 7. 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
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E.4 | Principal exclusion criteria |
1. 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: o Sulphur hexafluoride o Macrogol 4000 o Distearoylphosphatidylcholine o Dipalmitoylphosphatidylglycerol sodium o Palmitic acid 2. Pregnant women 3. Subjects with severe cardiac or pulmonary disease as defined by the treating physician 4. Subjects with acute endocarditis and/or artificial heart valve 5. Subjects with acute systemic inflammation and/or sepsis 6. Subjects with hyperactive coagulation states and/or a recent thromboembolism 7. Subjects with end stage renal or hepatic disease 8. Subjects with known metal skull implants in the anatomical area of the temporal/parietal bones, or with anatomical formation of the head or ear that may interfere with proper headset placement, or with significant observable asymmetry in head formation 9. Subjects with known implanted deep brain stimulation devices 10. Subjects with known or suspected fracture(s) of the temporal/parietal skull bones, or with open skin injuries in the anatomical area of the temporal/parietal lobes 11. Subjects with known significant blood loss prior to or during the test procedure, SONAS® should not be used unless the blood pressure of the subject is verified to be stabilized 12. Subjects with axial (coronal) skull diameters of <12 cm or >18 cm 13. Subjects participating in another clinical investigation with an investigational drug or device within 3 months of enrollment or planned participation at any time during this clinical investigation 14. Previous participation in this clinical investigation 15. Employees of the clinical investigation site or the sponsor directly involved with the conduct of the clinical investigation, or immediate family members of any such individuals 16. Subjects committed to an institution by an order issued either by the courts or by an authority
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E.5 End points |
E.5.1 | Primary end point(s) |
• Measurement of the kinetic parameter time to peak (TTP) in the right and left brain hemisphere during the SONAS® test • Assessment of intra-individual differences in the parameter TTP in the right and left brain hemisphere during the SONAS® test • Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left brain hemisphere • Measurement of other kinetic parameters (e.g. TI, TA, hPmax_incline, Pmax, hPmax_recede, 80%Pmax_recede, and MTT) in the right and left brain hemisphere during the SONAS® test and evaluations as defined for TTP
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0; day 1 (24 hours after first SONAS test) |
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E.5.2 | Secondary end point(s) |
Frequency, severity, relationship (device, contrast agent, or procedure) and outcome of adverse events (AEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0; day 1 (24 hours after first SONAS test); day 4 (72 hours after second SONAS test) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To determine the safety and feasibility of detecting acoustic signals, enhanced by injection of Sonovue contrast agent, related to blood supply in subjects with acute LVO stroke by using the SONAS® device. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |