Intracranial HemorrhageNCT02654015
INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage
A study testing Apollo MIES and Medical Management in people with Intracranial Hemorrhage, run by J. Mocco at 7 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 22 to 84 years
- Conditions the study is for
- Intracranial Hemorrhage
- What is being tested?
- Apollo MIES and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jun 2017to 7 Sep 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
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 25Show fewer
- 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 4.
- 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: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
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.
Read the detailed description
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.
- Conditions
- Intracranial Hemorrhage
- Being tested
- Apollo MIES, Medical Management
- 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 MIESDevice
Also called ICH - Apollo System
Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
Medical ManagementOther
Also called MM, ICH - Medical Management
Subjects will receive best medical management for intracranial hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Medical Management plus Apollo MIES | Experimental | Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo System for clot evacuation. Receives: Device: Apollo MIES; Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled Within 730 Days of First Enrollment
Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment
Measured: 730 days
Number of Participants With Available mRS Score
Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days
Measured: 180 days
Secondary outcomes (8)
Stroke Impact Scale - Mobility
For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:
- 1 = could not do it at all
- 2 = very difficult
- 3 = somewhat difficult
- 4 = a little difficult
- 5 = not difficult at all Stroke Impact Scale full scale from 0-45, with higher score indicating better health outcomes
Measured: 180 days
Stroke Impact Scale - ADLs
For each item, the individual is asked to rate the level of difficulty of the item in the past 2 weeks using the following scale:
- 1 = could not do it at all
- 2 = very difficult
- 3 = somewhat difficult
- 4 = a little difficult
- 5 = not difficult at all
Stroke Impact Scale - ADL's full scale from 0-50, with higher score indicating better health outcomes.
Measured: 180 days
EQ-5D-5L
EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, may be converted into a single index value. scored as 1 = no problem to 5 = severe problem
Full scale from 0-25, with higher score indicating better health outcomes.
Measured: 180 days
Length of Hospital Stay
number of days of hospital stay
Measured: average of 14 days
Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3
Number of participants with modified Rankin score (mRS) less than or equal to 3 to assess global disability assessed.
The Modified Rankin Scale (mRS) The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 180 days
Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume
Predominantly or Only ICH: Number of participants who meet both criteria of reduction of reduction to < 15 cc total volume AND >60% reduction in hemorrhage volume on immediate post-treatment CT scan. Number of participants who meet both criteria of reduction of Hemorrhage volume as indication of surgical success.
Measured: 180 days
Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5
Predominantly or Only IVH: number of participants with IVH (mGraeb > 0) with an mGraeb score of less than or equal to 5 on day 7 CT scan. Number of participants with IVH (mGraeb > 0) with an mGraeb score of less than or equal to 5 as indication of surgical success.
Measured: Day 7
Number of Participants Who Died Within 90 Days of the Procedure
Rate of mortality as Safety Endpoint. Number of participants who died within 90 days of the procedure.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start30 Jun 2017
- Primary completion7 Sep 2022
- Study completion7 Sep 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
- 50 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
- NCT02654015
- Sponsor's protocol ID
- GCO 16-0027
- Status last verified
- Oct 2023
- First submitted
- 11 Jan 2016
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
- ClinicalTrials.gov ID
- NCT02654015
- Acronym / sponsor ID
- GCO 16-0027
- Conditions
- Intracranial Hemorrhage
- Keywords
- intracranial hemorrhage, neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- J. MoccoUniversity, hospital or other
- Collaborators
- MOUNT SINAI HOSPITAL, University at Buffalo
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Management plus Apollo MIES | Experimental | Device: Apollo MIES, Other: Medical ManagementSubjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo System for clot evacuation. |
Who may qualify
- Ages
- 22 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 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 MIESAlso: ICH - Apollo SystemSubjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System. | Device | Medical Management plus Apollo MIES |
| Medical ManagementAlso: MM, ICH - Medical ManagementSubjects will receive best medical management for intracranial hemorrhage | Other | Medical Management plus Apollo MIES |
Primary outcome
Number of Participants Enrolled Within 730 Days of First Enrollment
Time frame: 730 days
Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment
Number of Participants With Available mRS Score
Time frame: 180 days
Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days
8 secondary outcomes
Stroke Impact Scale - Mobility
Time frame: 180 days
Stroke Impact Scale - ADLs
Time frame: 180 days
EQ-5D-5L
Time frame: 180 days
Length of Hospital Stay
Time frame: average of 14 days
Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3
Time frame: 180 days
Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume
Time frame: 180 days
Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5
Time frame: Day 7
Number of Participants Who Died Within 90 Days of the Procedure
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- 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 MIES and Medical Management 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 10 inclusion and 25 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 22 Nov 2023. 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 22 Nov 2023). 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 Enrolled Within 730 Days of First Enrollment (time frame: 730 days). The study lists 2 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 22 Nov 2023.