A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms

Last updated: May 2, 2025
Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

MICRUSFRAME and GALAXY coils

Clinical Study ID

NCT03642639
CNV_2017_01
  • Ages 21-80
  • All Genders

Study Summary

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is between 21 and 80 years of age

  2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable forembolization with coils

  3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion

Exclusion Criteria:

  1. Pre-planned staged procedure on unruptured aneurysm

  2. More than one aneurysm requiring treatment during the course of study

  3. Fusiform aneurysm

Study Design

Total Participants: 850
Treatment Group(s): 1
Primary Treatment: MICRUSFRAME and GALAXY coils
Phase:
Study Start date:
August 23, 2018
Estimated Completion Date:
September 30, 2025

Study Description

A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Connect with a study center

  • Az Groeninge

    Kortrijk,
    Belgium

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio 43604
    United States

    Site Not Available

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