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

Primary Purpose

Aneurysms

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MICRUSFRAME and GALAXY coils
Sponsored by
Cerenovus, Part of DePuy Synthes Products, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysms

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai HospitalRecruiting
  • Mercy Health St. Vincent Medical CenterRecruiting
  • Az GroeningeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coils

Arm Description

MICRUSFRAME and GALAXY coils

Outcomes

Primary Outcome Measures

Occlusion Rate
Occlusion rate at 12 Months post procedure

Secondary Outcome Measures

1. Packing Density
Packing density will be evaluated based on aneurysm volume and the coils used during the procedure.
2. Complete occlusion rate
Complete occlusion rate at 12 month follow-up
3. Recanalization Rate
Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up
4. Device related serious adverse events
Any device related serious adverse events will be reported through 12 month follow-up
5. Retreatment Rate
Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up
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.
7. Length of hospital stay
Hospital stay length will be recorded

Full Information

First Posted
July 11, 2018
Last Updated
October 10, 2023
Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03642639
Brief Title
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coils
Arm Type
Other
Arm Description
MICRUSFRAME and GALAXY coils
Intervention Type
Device
Intervention Name(s)
MICRUSFRAME and GALAXY coils
Intervention Description
MICRUSFRAME and GALAXY Coils
Primary Outcome Measure Information:
Title
Occlusion Rate
Description
Occlusion rate at 12 Months post procedure
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
1. Packing Density
Description
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
Title
2. Complete occlusion rate
Description
Complete occlusion rate at 12 month follow-up
Time Frame
12 month
Title
3. Recanalization Rate
Description
Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up
Time Frame
12 Months
Title
4. Device related serious adverse events
Description
Any device related serious adverse events will be reported through 12 month follow-up
Time Frame
12 Months
Title
5. Retreatment Rate
Description
Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up
Time Frame
12 Months
Title
6. Modified Rankin Score
Description
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.
Time Frame
12 Months
Title
7. Length of hospital stay
Description
Hospital stay length will be recorded
Time Frame
From enrollment to 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lillian Ma
Phone
9494668021
Email
lma46@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reade De Leacy
Organizational Affiliation
Mount Sinai Hospital, New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osama Zaidat
Organizational Affiliation
Mercy Health St. Vincent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reade De Leacy, MD
Facility Name
Mercy Health St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama Zaidat, MD, MS
Facility Name
Az Groeninge
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Francois, MD

12. IPD Sharing Statement

Learn more about this trial

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

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