Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
概览
- 阶段
- 不适用
- 干预措施
- Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
- 疾病 / 适应症
- Chronic Subdural Hematoma
- 发起方
- Cerenovus, Part of DePuy Synthes Products, Inc.
- 入组人数
- 376
- 试验地点
- 65
- 主要终点
- Effectiveness
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
详细描述
This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.
研究者
入排标准
入选标准
- •Pre-randomization mRS \</= 3
- •Confirmed diagnosis of chronic subdural hematoma
- •Completed informed consent
排除标准
- •Acute subdural hematoma
- •Prior treatment of target subdural hematoma
- •Markwalder assessment \>/= 3
- •Glasgow Coma Scale \< 9
- •Presumed microbial superinfection
- •CT or MRI evidence of intracranial tumor or mass lesion
- •Life expectancy \< 1 year
- •Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
- •Current involvement in another clinical trial that may confound study endpoints
研究组 & 干预措施
Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization
干预措施: Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Standard of Care Surgery Only
Standard of Care Surgery Only
干预措施: Standard of Care Surgery
Interventional Cohort: Treatment Arm
Standard of Care Medical Management + Embolization
干预措施: Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System
Standard of Care Medical Management Only
Standard of Care medical management only.
干预措施: Standard of Care Medical Management
结局指标
主要结局
Effectiveness
时间窗: 180 days post procedure
Hematoma recurrence/progression or requiring re-intervention
Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any Re-operation or Surgical Procedure on the cSDH at 6 Months
时间窗: At 6 months
Percentage of participants and odds ratio (OR) of participants with residual or re-accumulation of the cSDH (\>10 mm) at 6 months as assessed by an independent core laboratory or re-operation or surgical procedure on the cSDH at 6 months post-randomization in the treatment with eMMA vs. standard of care is represented. Residual or re-accumulation of the cSDH \>10 mm was a threshold included in the guidelines for surgical evacuation and was considered to be of prognostic importance given its association with mortality, decreased quality of life, and complications from new or repeat procedures.
Percentage of Participants With All Adverse Events (AEs)
时间窗: From randomization up to 6 months
An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All AEs including both serious and non serious were reported.
次要结局
- Number of Participants With Complete Resolution of the cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory(At Months 3, 6 and 12)
- Median Time to Achieve Complete Resolution of the cSDH(Up to 12 months)
- Number of Participants Who Developed an Acute Component of Their Existing cSDH or a New cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory(At Months 3, 6, and 12)
- Number of Participants With Good Functional Outcome at 3 Months (Modified Rankin Score [mRS] 0-2 or no Worsening From Baseline if Baseline mRS Greater Than Equal to [>=] 3)(At Month 3)
- Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory(Baseline , Months 3, 6 and 12)
- Number of Participants With Greater Than (>) 50% Reduction in Hematoma Volume at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory(Month 3, Month 6 and Month 12)
- Percentage of Participants Who Required a Surgical Procedure on the cSDH Within 3 and 6 Months Post-Randomization(From randomization up to Months 3 and 6)
- Number of Participants Who Required More Than One Surgical Procedure on the cSDH Within 3, 6, and 12 Months Post-Randomization(From randomization up to Months 3, 6 and 12)
- Number of Participants Who Required a Surgical Procedure on the cSDH Within 12 Months(From randomization up to Months 12)
- Number of Participants With Shift From Baseline in Modified Rankin Scale (mRS) Score at 3, 6, and 12 Months(Baseline, Months 3, 6 and 12)
- Number of Participants With Death, Stroke, Myocardial Infarction (MI) or Thromboembolic Complications Within 3, 6, and 12 Months as Assessed by the Clinical Events Committee (CEC)(From randomization up to Months 3, 6 and 12)
- Number of Participants With New Onset of Seizures Within 3, 6, and 12 Months as Assessed by the Clinical Events Committee (CEC)(From randomization up to Months 3, 6, and 12)
- Number of Participants With Shift From Baseline in Mini-Mental State Exam (MMSE) Score at 6 Months(Baseline, 6 months)
- Number of Participants With Shift From Baseline in Markwalder Neurological Grading Scale (MGS) at 3, 6, and 12 Months(Baseline, Months 3, 6 and 12)
- Hospital Days and Intensive Care Unit (ICU) Days(From randomization up to 6 months)
- Change From Baseline in EuroQol-5 Dimension-5 Levels (EQ-5D-5L) Score at 6 Months(Baseline, Month 6)