NCT03342664已完成不适用
MIND: A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 33
- 主要终点
- Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
研究概览
简要总结
The primary objective of this multicenter randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of intracerebral hemorrhage (ICH).
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
180 day mRS is blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 18 and ≤ 80
- •Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
- •Hemostasis as confirmed by no arterial spot sign (may perform additional scan(s) every 6 hours to demonstrate hemostasis)
- •GCS ≥ 5 and ≤ 15
- •Historical mRS 0 or 1
- •Symptom onset < 24 hours prior to initial CT/MR
- •MIS must be initiated within 72 hours of ictus/bleed
- •SBP must be < 180 mmHg and controlled at this level for at least 6 hours
排除标准
- •"Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
- •Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc.), aneurysm, and/or neoplasm
- •Hemorrhagic conversion of an underlying ischemic stroke
- •Infratentorial hemorrhage
- •Primary thalamic ICH (where the center of the hemorrhage emulates from the thalamus)
- •Associated intra-ventricular hemorrhage requiring treatment for IVH-related mass effect or shift due to trapped ventricle (EVD for ICP management is allowed)
- •Midbrain extension/involvement
- •Absolute contraindication to CTA, conventional angiography and MRA
- •Coagulation Issues
- •Absolute requirement for long-term anti-coagulation (e.g., mechanical valve replacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
- •Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- •Platelet count < 100 x 10^3 cells/mm3 or known platelet dysfunction
- •INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
- •Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux) within last 48 hours
- •Patient Factors
- •Traumatic ICH
- •High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation) and/or symptomatic carotid stenosis
- •Requirement for emergent surgical decompression or uncontrolled ICP after EVD
- •Unable to obtain consent per Institution Review Board/Ethics Committee policy
- •Pregnancy or positive pregnancy test (either serum or urine). Women of child-bearing potential must have a negative pregnancy test prior to enrollment
- •Severe active infection requiring treatment (e.g. sepsis or purulent wound) at the time of enrollment
- •Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
- •Based on investigator's judgement, patient is unwilling or unable to comply with protocol follow up appointment schedule
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator would interfere with adherence to study requirements
- •Currently participating in another interventional (drug, device, etc) clinical trial. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
研究组 & 干预措施
Artemis + Medical Management (MIS)
Experimental
Minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device with medical management
干预措施: Artemis + Medical Management (Device)
Best Medical Management Alone (MM)
Active Comparator
Best medical management alone per standard of care at treating institution
干预措施: Best Medical Management Alone (MM) (Other)
结局指标
主要结局
Global Disability (Functional Outcome) Assessed Via the Ordinal Modified Rankin Score (mRS)
时间窗: 180 days
Modified Rankin scale measures degree of disability or functional impairment on a scale of 0 (no symptoms) to 5 (severe disability), 6 (expired), where higher scores mean a worse outcome
Rate of Mortality
时间窗: 30 days
次要结局
- Length of ICU(# of days from admission (up to one year))
- Functional Outcomes Measured Via Utility Weighted Modified Rankin Score (mRS)(180 days)
- Functional Outcomes Measured Via Modified Ordinal Rankin Score (mRS)(365 days)
- Quality of Life Assessed Via Stroke Impact Scale(180 and 365 days)
- VAS Quality of Life Assessed Via EQ-5D-5L(180 and 365 days)
- Length of Hospital Stay(Admission to hospital discharge (up to one year))
- Length of Procedure(Time from initial sheath placement to final sheath removal)
- Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 3(180 days)
- Functional Outcomes Measured Via Modified Rankin Score (mRS) of ≤ 2(180 days)
研究者
研究点 (33)
Loading locations...
相似试验
已完成
3 期
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar StenosisLow Back PainLeg PainLumbar Spinal StenosisSpondylolisthesisNCT00405691Impliant, Ltd.450
Unknown
不适用
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV FistulaArteriovenous FistulaNCT04393688BrosMed Medical Co., Ltd168
已完成
3 期
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV MelanomaMelanomaNCT00324155Bristol-Myers Squibb681
进行中（未招募）
不适用
RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)Aortic Valve StenosisHeart Valve DiseasesNCT04160130Optimapharm432
已完成
3 期
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)Iron Deficiency AnemiaNCT00982007American Regent, Inc.997