INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Number of Participants With Available mRS Score
研究概览
简要总结
The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.
详细描述
Objective
The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo or Artemis Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.
Study Design: This study will be a prospective, multi-centered trial that will enroll 50 patients at up to 10 United States (US) centers.
Patient Population: Patients with moderate-large volume (20-80 cc) supratentorial intracerebral hemorrhage (ICH) who present within 24 hours of symptom onset. Enrolled patients will receive minimally invasive endoscopic evacuation with the Apollo system or Artemis Device.
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 or cerebrum. In the present study, the researchers propose to investigate the feasibility of studying this patient population for eventual implementation of efficacy trials.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 22 and ≤ 80, or age < 85 with baseline mRS=0
- •Supratentorial ICH of volume ≥ 30 mL < 80 ml (measured using A x B X C/2 method)
- •CT/MR demonstrates ICH stability (< 5 cc growth) at 6 hours after admission scan
- •If the initial stability scan shows growth, a second stability scan can be performed q12h until stability is demonstrated or until eligibility for the study has lapsed.
- •NIHSS ≥ 6
- •Presenting GCS 5 - 15
- •Historical mRS 0 to 2
- •Symptom onset < 24 h prior initial CT
- •Apollo MIES can be initiated within 72h of ictus/bleed
- •SBP can be controlled < 160 mmHg and sustained at this level for at least 6 hours
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
- •Large 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 103 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)
- •Patient Factors
- •Presenting GCS 3 or
- •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
Number of Participants With Available mRS Score
时间窗: 180 days
Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days
Number of Participants Enrolled Within 730 Days of First Enrollment
时间窗: 730 days
Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment
次要结局
- Stroke Impact Scale - Mobility(180 days)
- EQ-5D-5L(180 days)
- Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3(180 days)
- Number of Participants Who Died Within 90 Days of the Procedure(90 days)
- Stroke Impact Scale - ADLs(180 days)
- Length of Hospital Stay(average of 14 days)
- Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume(180 days)
- Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5(Day 7)
研究者
J. Mocco
Professor
Icahn School of Medicine at Mount Sinai