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

NCT ID: NCT02654015

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2022-09-07

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.

Conditions

Intracranial Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical Management plus Apollo MIES

Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo System for clot evacuation.

Group Type: EXPERIMENTAL

Apollo MIES

Intervention Type: DEVICE

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

Medical Management

Intervention Type: OTHER

Subjects will receive best medical management for intracranial hemorrhage

Interventions

Apollo MIES

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

Intervention Type: DEVICE

Medical Management

Subjects will receive best medical management for intracranial hemorrhage

Intervention Type: OTHER

Other Intervention Names

ICH - Apollo System; MM; ICH - Medical Management

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MOUNT SINAI HOSPITAL

OTHER

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: collaborator

J. Mocco

OTHER

Sponsor Role: lead

Responsible Party

J. Mocco

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

J Mocco, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

George Washington University

Washington D.C., District of Columbia, United States

University of Louisville

Louisville, Kentucky, United States

University of Buffalo

Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GCO 16-0027

Identifier Type: -

Identifier Source: org_study_id