Intracranial Hemorrhage
Conditions
Keywords
intracranial hemorrhage, neurosurgery
Brief 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). 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.
Interventions
DEVICEApollo MIES
Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
OTHERMedical Management
Subjects will receive best medical management for intracranial hemorrhage
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 84 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Enrolled Within 730 Days of First Enrollment | 730 days | Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment |
| Number of Participants With Available mRS Score | 180 days | Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-5L | 180 days | 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. |
| Length of Hospital Stay | average of 14 days | number of days of hospital stay |
| Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3 | 180 days | 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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Stroke Impact Scale - Mobility | 180 days | 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 |
| Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5 | Day 7 | 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. |
| Number of Participants Who Died Within 90 Days of the Procedure | 90 days | Rate of mortality as Safety Endpoint. Number of participants who died within 90 days of the procedure. |
| Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume | 180 days | 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. |
| Stroke Impact Scale - ADLs | 180 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medical Management Plus Apollo MIES Subjects received best medical management for ICH plus they received the MIES surgery and use of the Apollo System for clot evacuation.
Apollo MIES: Subjects received best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
Medical Management: Subjects received best medical management for intracranial hemorrhage | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 12 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Medical Management Plus Apollo MIES |
|---|---|
| Age, Continuous | 61.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 9 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 | 15 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 12 / 50 |
| other Total, other adverse events | 25 / 50 |
| serious Total, serious adverse events | 24 / 50 |
Outcome results
Primary
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
Time frame: 730 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Management Plus Apollo MIES | Number of Participants Enrolled Within 730 Days of First Enrollment | 23 Participants |
Primary
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
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Management Plus Apollo MIES | Number of Participants With Available mRS Score | 47 Participants |
Secondary
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.
Time frame: 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Management Plus Apollo MIES | EQ-5D-5L | 12.5 score on a scale |
Secondary
Length of Hospital Stay
number of days of hospital stay
Time frame: average of 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Management Plus Apollo MIES | Length of Hospital Stay | 13.5 days |
Secondary
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.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Management Plus Apollo MIES | Number of Participants Who Died Within 90 Days of the Procedure | 7 Participants |
Secondary
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.
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Management Plus Apollo MIES | Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume | 28 Participants |
Secondary
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.
Time frame: Day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Management Plus Apollo MIES | Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5 | 19 Participants |
Secondary
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. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: 180 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medical Management Plus Apollo MIES | Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3 | 22 Participants |
Secondary
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.
Time frame: 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Management Plus Apollo MIES | Stroke Impact Scale - ADLs | 33 score on a scale |
Secondary
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
Time frame: 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medical Management Plus Apollo MIES | Stroke Impact Scale - Mobility | 31 score on a scale |