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

Completed · Not applicable

Conditions studied: Intracranial Hemorrhage

In brief

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.

Key facts

Study ID

NCT02654015

Run by

J. Mocco

People needed

50

Starts

2017-06-30

Expected to finish

2022-09-07

Last updated by the study team

2023-11-22

Who can join

Age: 22 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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