Intracranial Hemorrhage
Conditions
Keywords
Intracranial hemorrhage, Neurosurgery
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.
Interventions
DEVICEApollo 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.
DEVICEArtemis 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.
Sponsors
MOUNT SINAI HOSPITAL
University at Buffalo
J. Mocco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Length of Hospital Stay | average of 17 days | — |
| Number of Participants Requiring VPS | average of 17 days | Number of participants requiring Ventriculoperitoneal Shunt (VPS) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Patients With Brain Hemorrhage |
|---|---|
| Age, Continuous | 63.5 years |
| Cocaine or methamphetamine use | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Intracerebral hemorrhage (ICH) volume | 30.3 milliliters |
| Location of intracerebral hemorrhage Deep | 18 Participants |
| Location of intracerebral hemorrhage Lobar | 20 Participants |
| Medical comorbidities Diabetes | 6 Participants |
| Medical comorbidities Hypertension | 28 Participants |
| Medical comorbidities Other cardiovascular disease | 0 Participants |
| mRS before stroke 0 | 30 Participants |
| mRS before stroke 1 | 3 Participants |
| mRS before stroke 2 | 2 Participants |
| mRS before stroke 3 | 3 Participants |
| On anticoagulant therapy | 6 Participants |
| On antihypertensive therapy | 22 Participants |
| On antiplatelet therapy | 11 Participants |
| On NSAID therapy | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 22 Participants |
| Tobacco use Currently smoking (or quit within the last 6 months) | 9 Participants |
| Tobacco use Never smoked | 23 Participants |
| Tobacco use Previously smoked (quit > 6 months ago) | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 38 |
| other Total, other adverse events | 25 / 38 |
| serious Total, serious adverse events | 20 / 38 |
Outcome results
Primary
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
Time frame: 180 days
Population: one participant lost to follow-up after 1 month.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Brain Hemorrhage | Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3 | mRS ≤ 3 | 17 Participants |
| Patients With Brain Hemorrhage | Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3 | mRS > 3 | 20 Participants |
Primary
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
Time frame: immediately post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Brain Hemorrhage | Number of Participants With Surgical Success Rate | 27 Participants |
Primary
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
Time frame: 7 days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Brain Hemorrhage | Number of Participants With Surgical Success Rate Regarding IVH | 14 Participants |
Primary
Rate of Mortality
Time frame: 30 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Brain Hemorrhage | Rate of Mortality | 1 Participants |
Secondary
Length of Hospital Stay
Time frame: average of 17 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients With Brain Hemorrhage | Length of Hospital Stay | 14.5 days |
Secondary
Modified Rankin Score (mRS) at 30 Days
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
Time frame: 30 days post-procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 0 | 1 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 1 | 2 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 2 | 1 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 3 | 6 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 4 | 16 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 5 | 7 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | 6 | 1 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 30 Days | Unavailable | 4 Participants |
Secondary
Modified Rankin Score (mRS) at 90 Days
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
Time frame: 90 days post-procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 4 | 6 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 5 | 5 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 0 | 2 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 1 | 2 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 2 | 5 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 3 | 8 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | 6 | 2 Participants |
| Patients With Brain Hemorrhage | Modified Rankin Score (mRS) at 90 Days | Unavailable | 8 Participants |
Secondary
Number of Participants Requiring VPS
Number of participants requiring Ventriculoperitoneal Shunt (VPS)
Time frame: average of 17 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Brain Hemorrhage | Number of Participants Requiring VPS | 3 Participants |