Trial Outcomes & Findings for INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage (NCT NCT02654015)
NCT ID: NCT02654015
Last Updated: 2023-11-22
Results Overview
Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
730 days
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
12
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage
Baseline characteristics by cohort
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Age, Continuous
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 730 daysNumber of participants enrolled within 730 days of first enrollment to determine rate of recruitment
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Number of Participants Enrolled Within 730 Days of First Enrollment
|
23 Participants
|
PRIMARY outcome
Timeframe: 180 daysRate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Number of Participants With Available mRS Score
|
47 Participants
|
SECONDARY outcome
Timeframe: 180 daysFor 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
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Stroke Impact Scale - Mobility
|
31 score on a scale
Interval 12.5 to 41.5
|
SECONDARY outcome
Timeframe: 180 daysFor 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.
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Stroke Impact Scale - ADLs
|
33 score on a scale
Interval 12.5 to 44.0
|
SECONDARY outcome
Timeframe: 180 daysEQ-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.
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
EQ-5D-5L
|
12.5 score on a scale
Interval 9.3 to 17.8
|
SECONDARY outcome
Timeframe: average of 14 daysnumber of days of hospital stay
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Length of Hospital Stay
|
13.5 days
Interval 7.2 to 22.8
|
SECONDARY outcome
Timeframe: 180 daysNumber 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.
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3
|
22 Participants
|
SECONDARY outcome
Timeframe: 180 daysPredominantly 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.
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 7Predominantly 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.
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5
|
19 Participants
|
SECONDARY outcome
Timeframe: 90 daysRate of mortality as Safety Endpoint. Number of participants who died within 90 days of the procedure.
Outcome measures
| Measure |
Medical Management Plus Apollo MIES
n=50 Participants
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
|
|---|---|
|
Number of Participants Who Died Within 90 Days of the Procedure
|
7 Participants
|
Adverse Events
Medical Management Plus Apollo MIES
Serious events: 24 serious events
Other events: 25 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Medical Management Plus Apollo MIES
n=50 participants at risk
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
|
|---|---|
|
Psychiatric disorders
Altered mental status
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.0%
1/50 • 180 days
|
|
General disorders
Chest pain
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Hematoma
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
ICH
|
10.0%
5/50 • 180 days
|
|
Cardiac disorders
Cardiac arrest
|
6.0%
3/50 • 180 days
|
|
Infections and infestations
Pneumonia
|
8.0%
4/50 • 180 days
|
|
Immune system disorders
Sepsis
|
4.0%
2/50 • 180 days
|
|
General disorders
Death
|
8.0%
4/50 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Seizure
|
4.0%
2/50 • 180 days
|
|
Surgical and medical procedures
Intraoperative hemorrhage
|
2.0%
1/50 • 180 days
|
|
Surgical and medical procedures
Postoperative hemorrhage
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Cerebral edema
|
4.0%
2/50 • 180 days
|
|
Gastrointestinal disorders
GI bleed
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Hydrocephalus
|
2.0%
1/50 • 180 days
|
|
Surgical and medical procedures
EVD Malfunction
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Ventriculitis
|
2.0%
1/50 • 180 days
|
|
Surgical and medical procedures
Ventriculostomy Malfunction
|
2.0%
1/50 • 180 days
|
|
General disorders
Increase lethargy/Encephalopathy
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Worsening of hemorrhage edema and midline shift
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
DVT
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Neuro decline
|
2.0%
1/50 • 180 days
|
Other adverse events
| Measure |
Medical Management Plus Apollo MIES
n=50 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • 180 days
|
|
Psychiatric disorders
Altered mental status
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.0%
2/50 • 180 days
|
|
Infections and infestations
UTI
|
6.0%
3/50 • 180 days
|
|
General disorders
Chest pain
|
2.0%
1/50 • 180 days
|
|
Cardiac disorders
Sinus bradycardia
|
4.0%
2/50 • 180 days
|
|
Blood and lymphatic system disorders
Hematoma
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
ICH
|
4.0%
2/50 • 180 days
|
|
Infections and infestations
Pneumonia
|
6.0%
3/50 • 180 days
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • 180 days
|
|
Immune system disorders
Sepsis
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Seizure
|
2.0%
1/50 • 180 days
|
|
Gastrointestinal disorders
Constipation
|
4.0%
2/50 • 180 days
|
|
Blood and lymphatic system disorders
Laryngeal edema
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Stroke
|
4.0%
2/50 • 180 days
|
|
Surgical and medical procedures
Postoperative hemorrhage
|
4.0%
2/50 • 180 days
|
|
Nervous system disorders
Tremor
|
2.0%
1/50 • 180 days
|
|
Infections and infestations
Fever
|
4.0%
2/50 • 180 days
|
|
General disorders
Desaturation
|
2.0%
1/50 • 180 days
|
|
General disorders
Pain
|
2.0%
1/50 • 180 days
|
|
General disorders
Headache
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • 180 days
|
|
General disorders
Hiccups
|
2.0%
1/50 • 180 days
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • 180 days
|
|
Psychiatric disorders
Delusions
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Hydrocephalus
|
2.0%
1/50 • 180 days
|
|
General disorders
Broken Hip
|
2.0%
1/50 • 180 days
|
|
General disorders
Right shoulder pain
|
2.0%
1/50 • 180 days
|
|
General disorders
Left hip pain
|
2.0%
1/50 • 180 days
|
|
Surgical and medical procedures
Amiodarone-induced hypothyroidism
|
2.0%
1/50 • 180 days
|
|
Gastrointestinal disorders
Bowel Perforation
|
2.0%
1/50 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Tract hemorrhage
|
2.0%
1/50 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • 180 days
|
|
Psychiatric disorders
Acute agitation
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Hypernatremia
|
2.0%
1/50 • 180 days
|
|
General disorders
Weakness
|
2.0%
1/50 • 180 days
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • 180 days
|
|
Surgical and medical procedures
Dislodged PEG tube
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Hypokalemia
|
2.0%
1/50 • 180 days
|
|
Surgical and medical procedures
Pneumothorax secondary to thoracentisis
|
2.0%
1/50 • 180 days
|
|
Cardiac disorders
Hypertension
|
2.0%
1/50 • 180 days
|
|
Infections and infestations
Otomastoiditis
|
2.0%
1/50 • 180 days
|
|
Endocrine disorders
Hyperglycemia
|
2.0%
1/50 • 180 days
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
2.0%
1/50 • 180 days
|
|
Infections and infestations
Wound infection
|
2.0%
1/50 • 180 days
|
|
Infections and infestations
Lung infection
|
2.0%
1/50 • 180 days
|
Additional Information
Samantha St. Elin
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-1497
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place