At a glance
ClinicalIndex Comparison Record- ✓Age ≥22 and ≤80 years, or age <85 with baseline mRS=0
- ✓Supratentorial ICH volume ≥30 mL and <80 mL
- ✓ICH stability at 6 hours (growth <5 cc)
- ✓NIHSS ≥6
- ✕Expanding hemorrhage on stability imaging
- ✕Spot sign on CTA
- ✕Secondary hemorrhage etiology (AVM, cavernous malformation, aneurysm, neoplasm)
- ✕Hemorrhagic transformation of ischemic stroke
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
INVEST: A Single Arm, Feasibility Study of Minimally Invasive Endoscopic Surgical Treatment With Apollo for Supratentorial Intracerebral Hemorrhage (ICH)
In Brief
A clinical study evaluating Apollo MIES and Medical Management for Intracranial Hemorrhage. Completed, enrolled 50 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.
Subjects will receive best medical management for intracranial hemorrhage