The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 319
- 试验地点
- 60
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)
详细描述
The study objective is to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery.
Imaging assessment by blinded core laboratory
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Subject whose age is ≥ 30 at the time of consent
- •Pre-morbid mRS (Modified Rankin Scale) 0-1 within the previous 12 months
- •cSDH measures ≥ 10 mm in greatest thickness
- •cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift
- •Imaging characteristics indicative of chronicity (≥ 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on Computed Tomography (CT))
- •Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or aphasia; gait impairment or imbalance; focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or seizure
- •Subject, or his/her legally authorized representative, understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent Form
- •Female Subjects of child-bearing potential must be able to provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial
- •Subject is able and willing to return to the investigational site for all follow-up visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol
排除标准
- •Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH
- •Subject with prior Embolization of either MMA
- •Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy
- •Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
- •Subject with a cSDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement)
- •cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy
- •Life expectancy of <1 year
- •Subject who presents with an intracranial mass other than subdural hematoma
- •Subject who presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
- •Subject with serum creatinine level > 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis
- •Subject with significant liver function impairment at the time of enrollment
- •Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
- •Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints
研究组 & 干预措施
SQUID
Embolization of the Middle Meningeal Artery (MMA)
干预措施: SQUID Embolization (Device)
SQUID
Embolization of the Middle Meningeal Artery (MMA)
干预措施: SQUID Embolization and Surgical Evacuation (Device)
No Embolization
Standard Management
For subjects in the surgery only group (i.e., surgical management but no adjunctive MMAE), the surgical evacuation was to occur within 48 hours of randomization. Surgery included hemorrhage evacuation through one or two burr-holes with irrigation of the hematoma (and the option for placement of a subgaleal or subdural drain) or twist-drill drainage, such as Subdural Evacuating Port System.
Subjects in the non-surgical management alone group were followed by the clinical team and treated as per the standard of care (SOC) established at the institution for the management of cSDH. Standard of care typically included cSDH monitoring, medical intervention to control symptoms, reversal or cessation of anti-coagulant and anti-platelet medications as well as the administration of anti-inflammatory medications (e.g., steroids, statins).
干预措施: Surgical Evacuation (Procedure)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: Within 180-days of intervention
Treatment failure is defined by the occurrence of any of the following events: * Re-operation (after index procedure) or surgical rescue * Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause
Primary Safety Endpoint
时间窗: Within 30-days from intervention
Major disabling stroke or any death
次要结局
- Any investigational device/procedure-related AE/SAE(Through 1-year visit)
- mRS (analyzed as shift)(180-day from intervention)