The Onyx™ Trial For The Embolization Of The Middle Meningeal Artery For Chronic Subdural Hematoma (OTEMACS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 247
- 试验地点
- 11
- 主要终点
- Recurrence rate in the Experimental group vs. the Control group
研究概览
简要总结
Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach might increase the likelihood of resolution and might prevent reaccumulation of Chronic Subdural Hematoma (CSDH). The purpose of the OTEMACS Trial is to assess the safety and effect on recurrence rate and functional outcome of endovascular treatment in patients with CSDH.
详细描述
The OTEMACS study is a prospective, multicenter clinical trial with randomized treatment allocation, open label treatment and blinded endpoint evaluation (PROBE), designed to demonstrate that MMA embolization via a minimally invasive endovascular approach combined with standard (surgical/conservative) management is superior to standard management alone, in reducing the rate of CSDH-related surgical interventions and the recurrence rate in patient with CSDH at 90 days.
Eligible symptomatic CSDH patients will be randomly assigned, in a 1:1 ratio, to receive either surgical treatment plus an adjuvant MMA embolization (ST+MMAE group; the Experimental arm) or surgical treatment alone (ST group; the Control arm).
Eligible symptomatic nonsurgically treated patients with CSDH will be randomized, in a 1:1 ratio, to MMA embolization (MMAE group; the Experimental arm) or conservative management (CM group; the Control arm).
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)
入排标准
- 年龄范围
- 18 Years 至 115 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years old at inclusion (no upper age limit).
- •CSDH confirmed on cranial imaging (e.g. CT/magnetic resonance imaging [MRI]), as documented by a radiologist.
- •One or more symptoms attributable to CSDH including headache, cognitive impairment, gait instability, seizure, mild focal neurologic deficit, speech disturbance, or decreased consciousness.
- •No significant pre-morbid disability (baseline mRS score ≤3).
- •Decision of conventional therapy (neurosurgeon blinded to the randomization group)
- •Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergency consent.
排除标准
- •CSDH developing with underlying conditions: vascular lesions, brain tumor, arachnoid cyst, or spontaneous intracranial hypotension.
- •CSDH that have a focal location (confined to the frontal or temporal base or the interhemispheric space without cerebral convexity involvement), is 10 mm or less in thickness, or have no mass effect (cortical flattening or midline shifting).
- •Known absence of vascular access or any local cause prohibiting femoral catheterization.
- •Known contrast or endovascular or anesthetic product allergy or contraindications.
- •Any contraindications to the use of the Onyx™.
- •Female who is known to be pregnant or lactating at time of admission.
- •Patient presenting severe or fatal co-morbidities or Life expectancy under 6 months that will likely interfere with improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- •Patient unable to be present or available for follow-up
- •Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g. severe dementia).
- •Current participation in another investigational drug or device study.
- •Major patients under court protection, guardianship or curatorship.
- •Not be affiliated to a French social security system or a beneficiary of such a system
结局指标
主要结局
Recurrence rate in the Experimental group vs. the Control group
时间窗: Within 90 days
The recurrence of CSDH is defined by: * radiological remaining of the hematoma with thickness \> 10 mm in the ipsilateral subdural space with or without any clinical presentation at 90 days (+/- 14 days) after the randomization OR * revision surgery (in surgical group) / surgical rescue (non-surgical group) for hematoma reaccumulation (as assessed
次要结局
- Quality of life assessed by the EuroQol (Quality of life) EQ-5D scale(At 90 days)
- Rate of recurrence of CSDH requiring revision surgery (in surgical group) or surgical rescue (in non-surgical group)(Within 90 days)
- Mortality rates at discharge(Within 7 days)
- Major disabling stroke at discharge(Within 7 days)
- Incidence of procedure-related and device-related serious adverse events (PRSAEs and DRSAEs)(Through 24 hours (-6/+24 hours) post endovascular treatment)
- Length of hospital stay for neurosurgery.(within 90 days)
- Change in hematoma volume (HV) in the Experimental group vs. the Control group(At 90 days)
- Quality of life assessed by the Barthel Index(At 90 days)
- Incidence of all-cause mortality(At 90 days)
- Shift on the modified Rankin Scale (mRS) score in the Experimental group vs. the Control group(At 90 days)
- Proportion of patients with favorable functional outcome, defined as mRS 0-3(At 90 days)
- Proportion of patients with good functional outcome, defined as mRS 0-2(At 90 days)
- Degree of disability (shift on the mRS combining scores of 5 and 6)(At 90 days)
- Distribution of utility weighted mRS (UW mRS)(At 90 days)