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

ID#: NCT02661672

Age: 22 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 01, 2016

End Date: January 01, 2019

Contact Information:
J Mocco, MD, MS
Nicole Smeck
(212) 241-2376
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.

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.