A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
809
MICRUSFRAME and GALAXY Coils
Occlusion Rate
Occlusion rate at 12 Months post procedure
Time frame: 12 Months
1. Packing Density
Packing density will be evaluated based on aneurysm volume and the coils used during the procedure.
Time frame: From enrollment to end of treatment at 12 months
2. Complete occlusion rate
Complete occlusion rate at 12 month follow-up
Time frame: 12 month
3. Recanalization Rate
Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up
Time frame: 12 Months
4. Device related serious adverse events
Any device related serious adverse events will be reported through 12 month follow-up
Time frame: 12 Months
5. Retreatment Rate
Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up
Time frame: 12 Months
6. Modified Rankin Score
Modified Rankin Score (Scale from 0-6) at 12 Months. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Arizona
Tucson, Arizona, United States
Mercy San Juan Medical Center
Carmichael, California, United States
University of California Irvine
Orange, California, United States
University of Florida
Gainesville, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Memorial Health University
Savannah, Georgia, United States
Rush University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Javon Bea Hospital
Rockford, Illinois, United States
...and 41 more locations
Time frame: 12 Months
7. Length of hospital stay
Hospital stay length will be recorded
Time frame: From enrollment to 12 Months