Intracranial HemorrhageNCT02661672
INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
A study testing Apollo Device and Artemis Device in people with Intracranial Hemorrhage, run by J. Mocco at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intracranial Hemorrhage
- What is being tested?
- Apollo Device and Artemis Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Oct 2016to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Buffalo
Buffalo, New York, 14260
Geisinger Medical Center
Danville, Pennsylvania, 17822
Prisma Health
Greenville, South Carolina, 29601
University of Louisville
Louisville, Kentucky, 40202
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Washington
Seattle, Washington, 98195
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracranial Hemorrhage
- Being tested
- Apollo Device, Artemis Device
- Keywords
- Intracranial hemorrhage, Neurosurgery
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo DeviceDevice
Also called ICH - Apollo System
The Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Apollo Device; Device: Artemis Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 7 days post-procedure
Rate of Mortality
Measured: 30 days post procedure
Secondary outcomes (4)
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
Measured: 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
Measured: 90 days post-procedure
Length of Hospital Stay
Measured: average of 17 days
Number of Participants Requiring VPS
Number of participants requiring Ventriculoperitoneal Shunt (VPS)
Measured: average of 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start14 Oct 2016
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Mocco
- Sponsor type
- University, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, University at Buffalo
- Responsible party
- Sponsor-investigator, J. Mocco, Icahn School of Medicine at Mount Sinai
- Investigators
- J Mocco, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661672
- Sponsor's protocol ID
- GCO 16-0028
- Status last verified
- May 2025
- First submitted
- 11 Jan 2016
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry
- ClinicalTrials.gov ID
- NCT02661672
- Acronym / sponsor ID
- GCO 16-0028
- Conditions
- Intracranial Hemorrhage
- Keywords
- Intracranial hemorrhage, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- J. MoccoUniversity, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, University at Buffalo
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Brain Hemorrhage | Experimental | Device: Apollo Device, Device: Artemis DeviceSubjects 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age 022 years or older
- Supratentorial brain hemorrhage, which may be:
- Patient does not qualify for the concurrent INVEST Feasibility study
Key exclusion criteria (22 listed)
- Imaging
- Coagulation Issues
- Patient Factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo DeviceAlso: ICH - Apollo SystemThe Apollo system has been cleared for the controlled aspiration of soft tissue and/or fluid during endoscopically guided neurosurgery of the ventricular system. | Device | Patients with Brain Hemorrhage |
| Artemis DeviceThe 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. | Device | Patients with Brain Hemorrhage |
Primary outcome
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3
Time frame: 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
Time frame: 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
Time frame: 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
Rate of Mortality
Time frame: 30 days post procedure
4 secondary outcomes
Modified Rankin Score (mRS) at 30 Days
Time frame: 30 days post-procedure
Modified Rankin Score (mRS) at 90 Days
Time frame: 90 days post-procedure
Length of Hospital Stay
Time frame: average of 17 days
Number of Participants Requiring VPS
Time frame: average of 17 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Mocco, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Device and Artemis Device in people with Intracranial Hemorrhage, run by J. Mocco at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3 (time frame: 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.