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

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Hemorrhage
• Intervention / Treatment: Device: Apollo Device; Device: Artemis Device

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • New York
    • Buffalo, New York, United States, 14260
      • University of Buffalo
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Prisma Health
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Brain Hemorrhage; 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.

Device: Apollo Device; The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.; Other Names: ICH - Apollo System; Device: Artemis Device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3	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	180 days
Number of Participants With Surgical Success Rate	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	immediately post-procedure
Number of Participants With Surgical Success Rate Regarding IVH	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	7 days post-procedure
Rate of Mortality		30 days post procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: J. Mocco
• Collaborators: University at Buffalo; MOUNT SINAI HOSPITAL
• Investigators: Principal Investigator: J Mocco, MD, MS, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2016
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimated): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Neurosurgery; Intracranial hemorrhage
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages
• Other Study ID Numbers: GCO 16-0028