Trial Outcomes & Findings for INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage (NCT NCT02661672)
NCT ID: NCT02661672
Last Updated: 2025-06-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
180 days
Results posted on
2025-06-04
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
4
|
Baseline Characteristics
INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage
Baseline characteristics by cohort
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Age, Continuous
|
63.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Tobacco use
Never smoked
|
23 Participants
n=99 Participants
|
|
Tobacco use
Previously smoked (quit > 6 months ago)
|
6 Participants
n=99 Participants
|
|
Tobacco use
Currently smoking (or quit within the last 6 months)
|
9 Participants
n=99 Participants
|
|
Cocaine or methamphetamine use
|
4 Participants
n=99 Participants
|
|
On anticoagulant therapy
|
6 Participants
n=99 Participants
|
|
On antiplatelet therapy
|
11 Participants
n=99 Participants
|
|
On NSAID therapy
|
0 Participants
n=99 Participants
|
|
On antihypertensive therapy
|
22 Participants
n=99 Participants
|
|
Medical comorbidities
Diabetes
|
6 Participants
n=99 Participants
|
|
Medical comorbidities
Hypertension
|
28 Participants
n=99 Participants
|
|
Medical comorbidities
Other cardiovascular disease
|
0 Participants
n=99 Participants
|
|
Location of intracerebral hemorrhage
Deep
|
18 Participants
n=99 Participants
|
|
Location of intracerebral hemorrhage
Lobar
|
20 Participants
n=99 Participants
|
|
mRS before stroke
0
|
30 Participants
n=99 Participants
|
|
mRS before stroke
1
|
3 Participants
n=99 Participants
|
|
mRS before stroke
2
|
2 Participants
n=99 Participants
|
|
mRS before stroke
3
|
3 Participants
n=99 Participants
|
|
Intracerebral hemorrhage (ICH) volume
|
30.3 milliliters
n=99 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: one participant lost to follow-up after 1 month.
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
Outcome measures
| Measure |
Patients With Brain Hemorrhage
n=37 Participants
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.
|
|---|---|
|
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3
mRS ≤ 3
|
17 Participants
|
|
Number of Participants With Modified Rankin Score (mRS) ≤ 3 or mRS > 3
mRS > 3
|
20 Participants
|
PRIMARY outcome
Timeframe: immediately post-procedureTechnical 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
Outcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Number of Participants With Surgical Success Rate
|
27 Participants
|
PRIMARY outcome
Timeframe: 7 days post-procedureTechnical 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
Outcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Number of Participants With Surgical Success Rate Regarding IVH
|
14 Participants
|
PRIMARY outcome
Timeframe: 30 days post procedureOutcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Rate of Mortality
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days post-procedure0: 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
Outcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Modified Rankin Score (mRS) at 30 Days
0
|
1 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
1
|
2 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
2
|
1 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
3
|
6 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
4
|
16 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
5
|
7 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
6
|
1 Participants
|
|
Modified Rankin Score (mRS) at 30 Days
Unavailable
|
4 Participants
|
SECONDARY outcome
Timeframe: 90 days post-procedure0: 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
Outcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Modified Rankin Score (mRS) at 90 Days
0
|
2 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
1
|
2 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
2
|
5 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
3
|
8 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
4
|
6 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
5
|
5 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
6
|
2 Participants
|
|
Modified Rankin Score (mRS) at 90 Days
Unavailable
|
8 Participants
|
SECONDARY outcome
Timeframe: average of 17 daysOutcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Length of Hospital Stay
|
14.5 days
Interval 9.3 to 24.0
|
SECONDARY outcome
Timeframe: average of 17 daysNumber of participants requiring Ventriculoperitoneal Shunt (VPS)
Outcome measures
| Measure |
Patients With Brain Hemorrhage
n=38 Participants
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.
|
|---|---|
|
Number of Participants Requiring VPS
|
3 Participants
|
Adverse Events
Patients With Brain Hemorrhage
Serious events: 20 serious events
Other events: 25 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Patients With Brain Hemorrhage
n=38 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Acute hemorrhage
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Acute inflammatory demyelinating polyneuropathy
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Infections and infestations
Aspiration pneumonia/fever
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
C. diff infection
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Cranioplasty infection
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Vascular disorders
Deep venous thrombosis
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Injury, poisoning and procedural complications
Facial fractures
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Vascular disorders
Hypotension
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Deep seated right brain lesion due to brain abscess
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Pneumonia
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Blood and lymphatic system disorders
Polycythemia vera
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Vascular disorders
Pulmonary embolism
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Nervous system disorders
R frontal ICH
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Sepsis secondary to aspiration
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Stroke
|
7.9%
3/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Syncope
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Wound infection
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Wound infection and cerebral abscess
|
2.6%
1/38 • up to 6 months post-procedure
|
Other adverse events
| Measure |
Patients With Brain Hemorrhage
n=38 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Acute encephalopathy
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Renal and urinary disorders
Acute kidney injury
|
7.9%
3/38 • up to 6 months post-procedure
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Aspiration pneumonia
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Immune system disorders
Back rash
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Cardiac disorders
Chest pain - cardiac
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Injury, poisoning and procedural complications
Craniotomy site oozing
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38 • up to 6 months post-procedure
|
|
General disorders
Fever
|
10.5%
4/38 • up to 6 months post-procedure
|
|
Vascular disorders
Hematoma
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Hydrocephalus
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Investigations
Hyperchloremia
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Investigations
Hypernatremia
|
7.9%
3/38 • up to 6 months post-procedure
|
|
Vascular disorders
Hypertension/hypertensive episode
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Investigations
Hypomagnesemia
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Investigations
Hypopotassemia
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Intraventricular hemorrhage
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
L great toe abscess
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Reproductive system and breast disorders
Pulmonary edema
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Vascular disorders
Pulmonary emboli
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Seizure
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Nervous system disorders
Stroke
|
5.3%
2/38 • up to 6 months post-procedure
|
|
Psychiatric disorders
Suicide attempt
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Investigations
Transaminitis
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
1/38 • up to 6 months post-procedure
|
|
Infections and infestations
Urinary tract infection
|
7.9%
3/38 • up to 6 months post-procedure
|
|
Renal and urinary disorders
Worsening of chronic kidney disease
|
2.6%
1/38 • up to 6 months post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place