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

• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03642639
• Collaborator: (none)
• Enrollment: 850
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 75.3
• Patients Per Site: 283.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aneurysms	Device: MICRUSFRAME and GALAXY coils	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 850 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 23, 2018
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Coils MICRUSFRAME and GALAXY coils	Device: MICRUSFRAME and GALAXY coils; MICRUSFRAME and GALAXY Coils

Outcome Measures

Primary Outcome Measures

1. Occlusion Rate [12 Months]

   Occlusion rate at 12 Months post procedure

Secondary Outcome Measures

1. 1. Packing Density [From enrollment to end of treatment at 12 months]

   Packing density will be evaluated based on aneurysm volume and the coils used during the procedure.

2. 2. Complete occlusion rate [12 month]

   Complete occlusion rate at 12 month follow-up

3. 3. Recanalization Rate [12 Months]

   Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up

4. 4. Device related serious adverse events [12 Months]

   Any device related serious adverse events will be reported through 12 month follow-up

5. 5. Retreatment Rate [12 Months]

   Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up

6. 6. Modified Rankin Score [12 Months]

   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.

7. 7. Length of hospital stay [From enrollment to 12 Months]

   Hospital stay length will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	New York	New York	United States	10029
2	Mercy Health St. Vincent Medical Center	Toledo	Ohio	United States	43604
3	Az Groeninge	Kortrijk		Belgium

Sponsors and Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.

Investigators

• Principal Investigator: Reade De Leacy, Mount Sinai Hospital, New York
• Principal Investigator: Osama Zaidat, Mercy Health St. Vincent Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
• ClinicalTrials.gov Identifier: NCT03642639
• Other Study ID Numbers: CNV_2017_01
• First Posted: Aug 22, 2018
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of Aug 9, 2022