EUCTR2018-001279-19-DE进行中（未招募）1 期
Evaluation of the SONAS® ultrasound device for the assessment of bilateral cerebral perfusion in subjects with acute stroke
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •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
研究者
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