A Prospective, Multi-center, Single Arm Study to Obtain Real World Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils Including the PulseRider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms
Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:
• Patient is between 21 and 80 years of age
• Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
• Patient is able and willing to comply with protocol and follow-up requirements
Locations
United States
New York
Mount Sinai Hospital
New York
Ohio
Mercy Health St. Vincent Medical Center
Toledo
Other Locations
Belgium
Az Groeninge
Kortrijk
Time Frame
Start Date: 2018-08-23
Completion Date: 2025-09-30
Participants
Target number of participants: 850
Treatments
Other: Coils
MICRUSFRAME and GALAXY coils
Authors
Reade De Leacy, Osama Zaidat, Olivier Francois
Related Therapeutic Areas
Sponsors
Leads: Cerenovus, Part of DePuy Synthes Products, Inc.