NCT02661672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

October 14, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2022

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

6.1 years

First QC Date

January 11, 2016

Results QC Date

May 19, 2025

Last Update Submit

May 19, 2025

Conditions

Intracranial Hemorrhage

Keywords

Intracranial hemorrhageNeurosurgery

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Modified Rankin Score (mRS) at 30 Days

    30 days post-procedure

  • Modified Rankin Score (mRS) at 90 Days

    90 days post-procedure

  • Length of Hospital Stay

    average of 17 days

  • Number of Participants Requiring VPS

    average of 17 days

Study Arms (1)

Patients with Brain Hemorrhage

EXPERIMENTAL

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 DeviceDevice: Artemis Device

Interventions

Apollo DeviceDEVICE

The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.

Also known as: ICH - Apollo System
Patients with Brain Hemorrhage
Artemis DeviceDEVICE

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.

Patients with Brain Hemorrhage

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Buffalo

Buffalo, New York, 14260, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Prisma Health

Greenville, South Carolina, 29601, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sydney Edwards
Organization
Icahn School of Medicine at Mount Sinai
sydney.edwards@mountsinai.org
212-241-2524

Study Officials

  • J Mocco, MD, MS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 22, 2016

Study Start

October 14, 2016

Primary Completion

November 16, 2022

Study Completion

November 16, 2022

Last Updated

June 4, 2025

Results First Posted

June 4, 2025

Record last verified: 2025-05

Locations

US(7)