N/A
Completed N=50
INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage
Source: ClinicalTrials.gov NCT02654015 ↗Enrolled (actual)
50
Serious AEs
48.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants Enrolled Within 730 Days of First Enrollment — 23 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Enrolled Within 730 Days of First Enrollment |
23 | — |
| PRIMARY Number of Participants With Available mRS Score |
47 | — |
| SECONDARY Stroke Impact Scale - Mobility |
31 | — |
| SECONDARY Stroke Impact Scale - ADLs |
33 | — |
| SECONDARY EQ-5D-5L |
12.5 | — |
| SECONDARY Length of Hospital Stay |
13.5 | — |
| SECONDARY Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3 |
22 | — |
| SECONDARY Number of Participants Who Meet Both Criteria of Reduction of Hemorrhage Volume |
28 | — |
| SECONDARY Number of Participants With IVH (mGraeb > 0) With an mGraeb Score of Less Than or Equal to 5 |
19 | — |
| SECONDARY Number of Participants Who Died Within 90 Days of the Procedure |
7 | — |
Eligibility Criteria
Inclusion Criteria
- Patient age ≥ 22 and ≤ 80, or age 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.
Data sourced from ClinicalTrials.gov (NCT02654015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.