INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage

Intracranial Hemorrhage Clinical Trial

Official title:

INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02654015
• Other study ID #: GCO 16-0027
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: September 7, 2022

Study information

• Verified date: October 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages

Intervention

Device:
• Apollo MIES
Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.

Other:
• Medical Management
Subjects will receive best medical management for intracranial hemorrhage

Locations

Country	Name	City	State
United States	University of Buffalo	Buffalo	New York
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Prisma Health	Greenville	South Carolina
United States	University of Louisville	Louisville	Kentucky
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Washington	Seattle	Washington
United States	George Washington University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
J. Mocco	MOUNT SINAI HOSPITAL, University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	730 days
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	180 days
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	180 days
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.	180 days
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.	180 days
Secondary	Length of Hospital Stay	number of days of hospital stay	average of 14 days
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.; - 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.	180 days
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.	180 days
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.	Day 7
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.	90 days