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Safety of Apollo Micro Catheter in Pediatric Patients

NCT02085278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-01-25

No results posted yet for this study

Summary

This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).

Conditions

  • Brain Arteriovenous Malformation
  • Brain Vascular Malformations
  • Vein of Galen Malformation

Interventions

DEVICE

Apollo Micro Catheter device

Detachable Tip Micro catheter

Sponsors & Collaborators

  • St. Luke's-Roosevelt Hospital Center

    lead OTHER

Principal Investigators

  • Ahmed Otokiti, MBBS · St. Luke's-Roosevelt Hospital Center

  • Alejandro Berenstein, M.D · St. Luke's-Roosevelt Hospital Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085278 on ClinicalTrials.gov