INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage

Not Applicable

Completed

Conditions: Intracranial Hemorrhage

Interventions: Device: Apollo Device
Device: Artemis Device

Registration Number: NCT02661672

Lead Sponsor: J. Mocco

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Patient age 022 years or older
Supratentorial brain hemorrhage, which may be:
1. Intracerebral (ICH)
2. Primarily Intracerebral (ICH) with a component of intraventricular hemorrhage (IVH)
3. Primarily intraventricular hemorrhage (IVH) with a component of ICH
4. Intraventricular hemorrhage (IVH)
Patient does not qualify for the concurrent INVEST Feasibility study

Exclusion Criteria

Imaging
- 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Brain Hemorrhage	Artemis Device	Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation.
Patients with Brain Hemorrhage	Apollo Device	Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo or Artemis System for clot evacuation.

Primary Outcome Measures

Name	Time	Method
Rate of Mortality	30 days post procedure
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3	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	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	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

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	average of 17 days
Number of Participants Requiring VPS	average of 17 days	Number of participants requiring Ventriculoperitoneal Shunt (VPS)
Modified Rankin Score (mRS) at 30 Days	30 days post-procedure	0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Modified Rankin Score (mRS) at 90 Days	90 days post-procedure	0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Trial Locations

Locations (7): George Washington University
🇺🇸
Washington, District of Columbia, United States
Prisma Health
🇺🇸
Greenville, South Carolina, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
University of Washington
🇺🇸
Seattle, Washington, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
University of Buffalo
🇺🇸
Buffalo, New York, United States
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States