Safety and Performance of the Delta System in the Treatment of Vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH) Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 23
- 试验地点
- 13
- 主要终点
- Device or procedure related (possibly, probably, or definitely) serious adverse events rate, from the treatment period and up to 30 days.
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the Delta system in the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage (aSAH) patients.
详细描述
The Delta system is intended to deliver electrical modulation signal to the carotid body, to result in cerebral vasodilation and blood flow augmentation in the brain, for treatment of patients suffering from vasospasm post aSAH.
In this clinical trial the Delta system in intended to be used on patients who have their ruptured aneurysm secured, hospitalized in the neuro ICU (Intensive Care Unit) and are anesthetized and intubated, diagnose as suffer from cerebral vasospasm, who fulfill all the inclusion criteria and none of the exclusion as detailed in the study protocol.
The system is intended to be used for up to 7 days under hospital supervision that is routinely provided for stabilizing patients following SAH and securing aneurysms. Follow up period is 30 days after end of treatment.
The Delta system is comprised from two main elements: Electrical Stimulation Unit (ESU) and Delivery kit.The ESU is a reusable external autonomic stimulator unit, cable and graphic user interface (GUI) software based on a PC tablet. The delivery kit is a disposable stimulating leads shaft and accessories.
The procedure includes insertion of the leads shaft over a guiding needle via patient neck, so electrodes are positioned adjacent the carotid bodies. Therapy parameters are set by the physician and monitoring is continued during patient hospitalization to determine when therapy can be discontinued and shaft removed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female older than 18 years of age and no more than 75 years of age.
- •aSAH patients with secured aneurysm.
- •Patient has cerebral vasospasm and is anesthetized and intubated.
- •Cerebral vasospasm is manifested by:
- •Mean Flow Velocity (MFV) >120 cm/sec in the intracranial ICA (Internal carotid artery), MCA (middle cerebral artery) or ACA (anterior cerebral artery) or MFV >110 cm/sec in the PCA, or >85 cm/sec in the vertebral or basilar arteries, as measured by TCD (Trans Cranial Doppler).
- •Extra/intracranial ratio for the carotid watershed (MCA, ACA, intracranial ICA)>3, or a proximal/distal ratio for the vertebrobasilar (VB) system >
- •Affected/contralateral MCA MFV ratio ≥1.
- •Affected / baseline MCA MFV ratio ≥1.
- •Vasoconstriction of at least 33% in at least one of the main cerebral arteries, measured by Angiography (Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA).
- •Hemodynamically stable, including subjects who are treated for fever, hydrocephalus, rebleeding, infection or metabolic abnormalities and are stable.
- •For pre-menopausal females - a negative pregnancy test, using an accepted method of birth control and avoid breast feeding for the duration of the trial
- •A legally Authorized representative have signed informed consent.
排除标准
- •WFNS score 5
- •Unsecured aneurysm or Intracranial/SAH of other than aneurysmal origin.
- •Signs attributable to serious aneurismal surgical procedure-related complications.
- •Patient underwent decompressive craniectomy.
- •S/p Carotid Endarterectomy, or other neck intervention.
- •Known carotid body tumor, past or present.
- •Hemodynamic instability due to cardiac arrhythmia or due to any other cause.
- •Had a myocardial infarction, unstable angina or syncope, congestive heart failure that require hospitalization or ejection fraction ≤ 40% within the past 3 months. Note: Elevated Troponin is expected after aSAH and will not exclude patients.
- •Had a stroke, within the past 1 year or transient ischemic attack at the last 3 months.
- •Any anatomical variation or thrombotic finding that according to the physician judgment is not eligible.
- •Renal insufficiency (Creatinine X2 of the normal).
- •Allergic to contrast media with no response to steroid pretreatment.
- •Are unable or unwilling to fulfill the protocol follow-up requirements
- •Are enrolled in another concurrent clinical trial, without prior approval of Samson NS and the PI.
- •Have an uncontrolled comorbid medical condition that would adversely affect their health if they are enrolled.
结局指标
主要结局
Device or procedure related (possibly, probably, or definitely) serious adverse events rate, from the treatment period and up to 30 days.
时间窗: 30 days
次要结局
- Decrease Mean Flow Velocity (MFV) of ≥15% below the maximal MVF measured prior to treatment, in at least one of the affected cerebral arteries, in at least one measuring during treatment(7 days)
- Increase diameter of ≥15% in at least one of the affected main cerebral arteries, measured by Digital Subtraction Angiography (DSA) or Computed Tomography Angiography (CTA)(7 days)
- Increase of ≥20% in CBF above baseline prior to treatment measured by the CerOx monitor system during treatment(7 days)
- Increase of ≥20% in PbtO2 above baseline prior to treatment measured by Licox® monitoring system during treatment(7 days)
- Mechanical performance of the Delta system(7 days)
- Electrical performance of the Delta system(7 days)