INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 13
- 主要终点
- Rate of Mortality
研究概览
简要总结
Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.
详细描述
Study Design: This study will be a prospective, non-randomized, multi-center, single arm registry that will enroll up to 50 patients, however may increase to 200 at up to 10 US centers.
Patient Population: Adult patients with supratentorial brain hemorrhages (ICH and/or IVH) who do not meet all INCLUSION criteria or who meet one or more EXCLUSION criteria for the INVEST trial, but who will ultimately undergo MIES with Apollo or Artemis at active INVEST centers.
Indication: The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems. The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. In the present study, the researchers propose to investigate the safety and efficacy of this system for the minimally invasive evacuation of brain hemorrhage - both IVH, IVH with ICH and ICH alone - in patients who do not qualify for the INVEST trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 022 years or older
- •Supratentorial brain hemorrhage, which may be:
- •Intracerebral (ICH)
- •Primarily Intracerebral (ICH) with a component of intraventricular hemorrhage (IVH)
- •Primarily intraventricular hemorrhage (IVH) with a component of ICH
- •Intraventricular hemorrhage (IVH)
- •Patient does not qualify for the concurrent INVEST Feasibility study
排除标准
- •Expanding hemorrhage on stability CT/MR scan
- •"Spot sign" identified on CTA (May perform a second CTA at 12 hours to demonstrate resolution)
- •Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVM etc), aneurysm, neoplasm
- •Hemorrhagic conversion of an underlying ischemic stroke
- •Infratentorial hemorrhage
- •Midbrain extension/involvement
- •Coagulation Issues
- •Absolute and imminent (within 7 days of treatment) requirement for long-term, full-dose, 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
- •Uncorrected platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
- •INR > 1.45, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
- •Patient Factors
- •High risk condition for ischemic stroke (high risk Afib (e.g., mitral stenosis with Afib), symptomatic carotid stenosis)
- •Requirement for emergent surgical decompression or uncontrolled ICP after EVD
- •Unable to obtain consent from patient or appropriate surrogate (for patients without competence)
- •Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] (Woman of child-bearing potential must have a negative pregnancy test prior to the study procedure.)
- •Evidence of active infection [indicated by fever (at or over 100.7 °F) and/or open draining wound] at the time of randomization
- •Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days.
- •Based on investigator's judgment, patient does not have the necessary mental capacity to participate or 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) research project.
结局指标
主要结局
Rate of Mortality
时间窗: 30 days post procedure
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3
时间窗: 180 days
Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS). 180-day global disability assessed via the modified Rankin score (mRS), categorized as either mRS ≤ 3 or mRS \> 3
Number of Participants With Surgical Success Rate
时间窗: immediately post-procedure
Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as reduction to \< 15 cc total volume AND \>60% reduction in hemorrhage volume on immediate post-treatment CT scan
Number of Participants With Surgical Success Rate Regarding IVH
时间窗: 7 days post-procedure
Technical Efficacy Endpoint measured by rate of surgical success. Surgical Success Rate is defined as Intraventricular hemorrhage (IVH): mGraeb score of \< 5 on day 7 CT scan
次要结局
- Length of Hospital Stay(average of 17 days)
- Number of Participants Requiring VPS(average of 17 days)
- Modified Rankin Score (mRS) at 30 Days(30 days post-procedure)
- Modified Rankin Score (mRS) at 90 Days(90 days post-procedure)
研究者
J. Mocco
Professor
Icahn School of Medicine at Mount Sinai