脑膜中动脉栓塞治疗慢性硬膜下血肿 (STEM) 的 SQUID 试验 (STEM)
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Heidelberg、德国
- Universitatsklinikum Heidelberg
-
Nuremberg、德国
- Klinikum Nurnberg Sud
-
-
-
-
-
Caen、法国、14000
- CHU côte de Nacre
-
Le Kremlin-Bicêtre、法国、94275
- CHU Hopital Bicetre
-
Paris、法国
- Hôpital Pitié Salpêtrière
-
Reims、法国
- CHU Hopital Maison Blanche
-
-
-
-
Arizona
-
Phoenix、Arizona、美国、85013
- Barrow Neurological Institute
-
Tucson、Arizona、美国、85711
- Carondolet St. Joseph's
-
-
California
-
Riverside、California、美国、92501
- Riverside Community hospital
-
Santa Barbara、California、美国、93105
- Santa Barbara Cottage Hospital
-
Thousand Oaks、California、美国、92360
- Los Robles Hospital and Medical Center
-
-
Colorado
-
Englewood、Colorado、美国、80113
- Swedish Medical Center
-
-
Florida
-
Jacksonville、Florida、美国、32207
- Baptist Health
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory University
-
Marietta、Georgia、美国、30060
- Wellstar Kennestone Hospital
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- University of Kansas
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins Medicine
-
-
Nebraska
-
Omaha、Nebraska、美国、68106
- Nebraska Health
-
-
New Jersey
-
Summit、New Jersey、美国、07901
- Overlook Medical Center
-
-
New York
-
New York、New York、美国、10016
- NYU Langone Health
-
Stony Brook、New York、美国、11794
- Stony Brook University
-
The Bronx、New York、美国、10467
- Montefiore Medical Center
-
-
Pennsylvania
-
Danville、Pennsylvania、美国、17822
- Geisinger Medical Center
-
Hershey、Pennsylvania、美国、17918
- Penn State Health Hershey Medical Center
-
Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
-
-
Rhode Island
-
Providence、Rhode Island、美国、02903
- Rhode Island Hospital
-
-
Tennessee
-
Memphis、Tennessee、美国、38120
- Baptist Memorial Hospital
-
Memphis、Tennessee、美国、38104
- Methodist University Hospital
-
-
Utah
-
Salt Lake City、Utah、美国、84132
- University of Utah
-
-
Washington
-
Seattle、Washington、美国、98122
- Swedish Cherry Hill
-
-
West Virginia
-
Morgantown、West Virginia、美国、26506
- West Virginia University
-
-
-
-
-
Madrid、西班牙、28007
- Gregorio Maranon Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 同意时年龄≥30岁的男性或女性受试者
- 过去 12 个月内的病前 mRS 0-1
- cSDH 测量的最大厚度≥ 10 mm
- 如局部皮质扁平化或中线偏移所示，cSDH 对下方大脑产生质量效应
- 指示慢性的成像特征（≥ 50% 的集合体积在计算机断层扫描 (CT) 上应与正常皮质灰质等密度或低密度）
- 受试者出现以下一种或多种神经系统症状：头痛；认知能力下降;言语困难或失语；步态障碍或不平衡；局灶性神经功能缺损（涉及一个或多个肢体或面部下垂的虚弱、感觉异常或感觉缺陷）；和/或癫痫发作
- 受试者或其合法授权代表了解程序的性质，同意参与研究并提供签署的知情同意书
- 有生育能力的女性受试者必须能够提供当前的阴性尿妊娠试验，并同意在整个试验期间采取适当的避孕方法
10. 受试者能够并愿意根据方案的要求返回研究地点进行所有后续访问（例如，30 天、90 天、180 天和 1 年）
排除标准：
- 先前进行过 cSDH 开颅手术或钻孔清除术的受试者
- 先前栓塞过任一 MMA 的受试者
- 受试者需要（根据主治外科医生的意见）进行全开颅或小开颅手术
- 需要紧急或紧急（评估后 1 小时内）硬膜下血肿清除的受试者
- 具有局灶性 cSDH 的受试者（仅限于额叶或颞底或半球间空间，没有大脑凸面受累）
- 由于血管病变、脑肿瘤、蛛网膜囊肿、自发性颅内低血压或继发于先前的开颅手术等潜在疾病而发展为 cSDH
- 预期寿命
- 出现硬膜下血肿以外的颅内肿块的受试者
- 出现具有占位效应和/或≥1 cm 或目前正在接受头部或颈部癌症或肉瘤放射治疗的脑膜瘤的受试者
- 入组时血清肌酐水平 > 3.0 mg/dL 的受试者（这将限制造影剂的使用）且未进行透析
- 受试者有明显的肝功能损害
- 对放射造影剂有危及生命过敏的受试者（除非过敏治疗是可以耐受的或可以通过药物治疗）
- 目前正在参加另一项临床研究的受试者
- 无法完成所需后续行动的受试者
- 怀孕和/或哺乳的女性受试者
- 目前正在参加另一项可能混淆当前研究终点的研究性研究方案的受试者
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：乌贼
脑膜中动脉栓塞术 (MMA)
|
使用 SQUID 非粘附性液体栓塞剂栓塞脑膜中动脉
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical of the sub-dural hematoma
|
|
有源比较器：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). |
硬膜下血肿的手术清除
Standard Medical Management
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Effectiveness Endpoint-Number of Participants With Treatment Failure
大体时间：On 180-day from intervention
|
Treatment failure as defined by the occurrence of any of the following events:
|
On 180-day from intervention
|
|
Primary Safety Endpoint-Number of Participants With Major Disabling Stroke or Any Death Within 30 Days of Intervention
大体时间：Within 30-days from intervention
|
Major disabling stroke or any death within 30-days from intervention.
|
Within 30-days from intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any Investigational Device/MMAE Procedure-related AE/SAE
大体时间：Through 1-year visit
|
Number of participants with an adverse event (AE) or serious adverse event (SAE) adjudicated as probably or causally related to the investigational device or Middle Meningeal Artery Embolization (MMAE) procedure.
|
Through 1-year visit
|
|
mRS Shift Analysis at 180-day Visit
大体时间：180-day from intervention
|
The modified Rankin Scale (mRS) is an ordinal scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death): 0: No symptoms
|
180-day from intervention
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
mRS ≤ 2 (Binary)
大体时间：180 days
|
The Modified Rankin Scale (mRS) is a clinician-reported measure used to assess the degree of functional disability or dependence in daily activities following a neurological event. This binary outcome dichotomizes the 7-point scale (0-6) into two categories: Favorable Outcome (mRS 0-2) and Unfavorable Outcome (mRS 3-6). A score of ≤ 2 signifies that the participant is functionally independent and capable of looking after their own affairs without assistance. Results will be reported as the proportion of participants in each treatment arm achieving a score of 0, 1, or 2 at the 180-day follow-up. |
180 days
|
|
Global Neurocognitive Performance
大体时间：Baseline and 180 Days
|
T-scores were used to convert raw data to standardized scale with a mean of 50 and a standard deviation of 10.
A higher T-score indicates better cognitive performance (a score near 40 indicates a low average to average range).
Global neurocognitive performance was assessed by taking the mean T-score for all individual neurocognitive markers (Hopkins Verbal Learning Tests (HVLT-R), Controlled Oral Word Association Test (COWAT), Animal Naming, and Trail making tests).
|
Baseline and 180 Days
|
|
EQ-5D-5L (Including EQ-VAS) Visual Analogue Scale
大体时间：180-day change from Baseline
|
The EQ VAS is a 20 cm vertical visual analogue scale that records the patient's self-rated health today.
It ranges from 0 (Worst health you can imagine) to 100 (Best health you can imagine).
|
180-day change from Baseline
|
|
EQ-5D-5L Index
大体时间：180 day change from Baseline
|
The EQ-5D-5L (EuroQol - 5 Dimension - 5 Level) is a standardized, patient-reported instrument used globally to measure health-related quality of life (HRQoL).
It assesses health across 5 dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-with 5 levels of severity.
The index score ranges from -0.59 to 1.0, where 1.0 represents 'full health' and 0.0 represents death.
A higher score indicates a better health-related quality of life.
Change is calculated as (180-Day score minus Baseline score)
|
180 day change from Baseline
|
|
Hospital Days
大体时间：Through 180 days
|
The number of days (mean) in hospital from baseline through 180 days.
|
Through 180 days
|
|
NIHSS
大体时间：90-day Change from Baseline
|
The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to objectively quantify the neurological impairment caused by a stroke. It consists of 15 items assessing areas such as level of consciousness, vision, motor function, sensation, and language. Score Range: Total scores range from 0 to 42. Interpretation: A score of 0 indicates normal function (no symptoms), while higher scores indicate more severe neurological deficit. This outcome measures the mean change in the total NIHSS score from baseline (at enrollment) to the 90-day follow-up |
90-day Change from Baseline
|
|
Intensive Care Unit (ICU) Days
大体时间：180 days
|
The total number of ICU days from baseline through 180 days.
|
180 days
|
|
Imaging Core Lab Assessments (cSDH Thickness and Midline Shift)
大体时间：180 days Change from Baseline
|
Core Lab Analysis of CT/MRI Images.
The thickness of the cSDH was documented separately for the left and right sides.
|
180 days Change from Baseline
|
合作者和调查者
赞助
调查人员
- 首席研究员：David Fiorella, MD, PhD、Stony Brook University Medical Center
- 首席研究员：Adam Arthur, MD, MPH、Semmes-Murphy Neurologic and Spine Institute
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.