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

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

Detailed Description
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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

Official Title
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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

Conditions
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Aneurysms

Intervention / Treatment
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* Device: MICRUSFRAME and GALAXY coils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pre-planned staged procedure on unruptured aneurysm More than one aneurysm requiring treatment during the course of study Fusiform aneurysm

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coils<br>MICRUSFRAME and GALAXY coils | Device: MICRUSFRAME and GALAXY coils<br>* MICRUSFRAME and GALAXY Coils<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion Rate | Occlusion rate at 12 Months post procedure | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Packing Density | Packing density will be evaluated based on aneurysm volume and the coils used during the procedure. | From enrollment to end of treatment at 12 months | 
| 2. Complete occlusion rate | Complete occlusion rate at 12 month follow-up | 12 month | 
| 3. Recanalization Rate | Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up | 12 Months | 
| 4. Device related serious adverse events | Any device related serious adverse events will be reported through 12 month follow-up | 12 Months | 
| 5. Retreatment Rate | Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up | 12 Months | 
| 6. Modified Rankin Score | Modified Rankin Score (Scale from 0-6) at 12 Months. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | 12 Months | 
| 7. Length of hospital stay | Hospital stay length will be recorded | From enrollment to 12 Months |