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

Aneurysms Clinical Trial

— STERLING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642639
• Other study ID #: CNV_2017_01
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Cerenovus, Part of DePuy Synthes Products, Inc.
• Contact: Lillian Ma
• Phone: 9494668021
• Email: lma46[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient is between 21 and 80 years of age

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

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

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysms
• Intracranial Aneurysm

Intervention

Device:
• MICRUSFRAME and GALAXY coils
MICRUSFRAME and GALAXY Coils

Locations

Country	Name	City	State
Belgium	Az Groeninge	Kortrijk
United States	Mount Sinai Hospital	New York	New York
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion Rate	Occlusion rate at 12 Months post procedure	12 Months
Secondary	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
Secondary	2. Complete occlusion rate	Complete occlusion rate at 12 month follow-up	12 month
Secondary	3. Recanalization Rate	Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up	12 Months
Secondary	4. Device related serious adverse events	Any device related serious adverse events will be reported through 12 month follow-up	12 Months
Secondary	5. Retreatment Rate	Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up	12 Months
Secondary	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
Secondary	7. Length of hospital stay	Hospital stay length will be recorded	From enrollment to 12 Months