NCT02654015

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 22, 2023

Completed
Last Updated

November 22, 2023

Status Verified

October 1, 2023

Enrollment Period

5.2 years

First QC Date

January 11, 2016

Results QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Intracranial Hemorrhage

Keywords

intracranial hemorrhageneurosurgery

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Enrolled Within 730 Days of First Enrollment

    Number of participants enrolled within 730 days of first enrollment to determine rate of recruitment

    730 days

  • Number of Participants With Available mRS Score

    Rate of Successful Follow up Obtainment based on number of participants with available mRS score at 180 days

    180 days

Secondary Outcomes (8)

  • Stroke Impact Scale - Mobility

    180 days

  • Stroke Impact Scale - ADLs

    180 days

  • EQ-5D-5L

    180 days

  • Length of Hospital Stay

    average of 14 days

  • Number of Participants With Modified Rankin Score (mRS) Less Than or Equal to 3

    180 days

  • +3 more secondary outcomes

Study Arms (1)

Medical Management plus Apollo MIES

EXPERIMENTAL

Subjects will receive best medical management for ICH plus they will receive the MIES surgery and use of the Apollo System for clot evacuation.

Device: Apollo MIESOther: Medical Management

Interventions

Apollo MIESDEVICE

Subjects will receive best medical management plus MIES (minimally invasive endoscopic surgery with use of the Apollo System.

Also known as: ICH - Apollo System
Medical Management plus Apollo MIES
Medical ManagementOTHER

Subjects will receive best medical management for intracranial hemorrhage

Also known as: MM, ICH - Medical Management
Medical Management plus Apollo MIES

Eligibility Criteria

Age22 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Buffalo

Buffalo, New York, 14260, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Prisma Health

Greenville, South Carolina, 29601, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice ManagementProfessional PracticeOrganization and AdministrationHealth Services Administration

Results Point of Contact

Title
Samantha St. Elin
Organization
Icahn School of Medicine at Mount Sinai
samantha.stelin@mountsinai.org
(212) 241-1497

Study Officials

  • J Mocco, MD, MS

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 13, 2016

Study Start

June 30, 2017

Primary Completion

September 7, 2022

Study Completion

September 7, 2022

Last Updated

November 22, 2023

Results First Posted

November 22, 2023

Record last verified: 2023-10

Locations

US(7)