INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage

Intracranial Hemorrhage Clinical Trial

Official title:

INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage: A Prospective Multicenter Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661672
• Other study ID #: GCO 16-0028
• Status: Completed
• Phase: N/A
• Start date: October 14, 2016
• Est. completion date: November 16, 2022

Study information

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

Clinical Trial Summary

Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.

Description:

Study Design: This study will be a prospective, non-randomized, multi-center, single arm registry that will enroll up to 50 patients, however may increase to 200 at up to 10 US centers.

Patient Population: Adult patients with supratentorial brain hemorrhages (ICH and/or IVH) who do not meet all INCLUSION criteria or who meet one or more EXCLUSION criteria for the INVEST trial, but who will ultimately undergo MIES with Apollo or Artemis at active INVEST centers.

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. In the present study, the researchers propose to investigate the safety and efficacy of this system for the minimally invasive evacuation of brain hemorrhage - both IVH, IVH with ICH and ICH alone - in patients who do not qualify for the INVEST trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Patient age 022 years or older

• Supratentorial brain hemorrhage, which may be:

1. Intracerebral (ICH)

2. Primarily Intracerebral (ICH) with a component of intraventricular hemorrhage (IVH)

3. Primarily intraventricular hemorrhage (IVH) with a component of ICH

4. Intraventricular hemorrhage (IVH)

• Patient does not qualify for the concurrent INVEST Feasibility study

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

• Midbrain extension/involvement

• Coagulation Issues

• Absolute and imminent (within 7 days of treatment) requirement for long-term, full-dose, 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

• Uncorrected platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

• INR > 1.45, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)

• Patient Factors

• 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 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.

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	modified Rankin score (mRS)	Clinical Efficacy Endpoint: global disability assessed via the modified Rankin score (mRS)	180 days
Primary	Surgical success rate	Technical Efficacy Endpoint measured by rate of surgical success	180 days
Primary	Rate of Mortality		30 days