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

May 12, 2026 updated by: Cerenovus, Part of DePuy Synthes Products, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
723

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Kortrijk, Belgium
        • Algemeen Ziekenhuis Groeninge
  • France
      • Amiens, France
        • Centre Hospitalier Universitaire d'Amiens Picardie
      • Bordeaux, France
        • Centre Hospitalier Universitaire De Bordeaux
      • Lille, France
        • Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille
      • Nancy, France
        • Praticien Hospitalier Université de Lorraine
      • Tours, France
        • Centre Hospitalier Régional Universitaire de Tours
  • Germany
      • Lübeck, Germany
        • Universitatsklinikum Schleswig Holstein
  • Israel
      • Nahariya, Israel
        • Galilee Hospital Naharyia
  • Italy
      • Milan, Italy
        • Ospedale Niguarda Ca' Granda
      • Roma, Italy
        • Policlinico Tor Vergata
      • Sicily, Italy
        • Ospedale Cannizzaro
  • Japan
      • Aichi, Japan
        • Aichi Medical University Hospital
      • Okayama, Japan
        • Okayama University Hospital
      • Osaka, Japan
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan
        • Tominaga Hospital
      • Sendai, Japan
        • Kohnan Hospital
      • Yokohama, Japan
        • Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital
  • Portugal
      • Porto, Portugal
        • Centro Hospitalar de Vila Nova de Gaia
  • Spain
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
  • Switzerland
      • Geneva, Switzerland
        • Hôpitaux Universitaires de Genève
      • Zurich, Switzerland
        • University Hospital Zurich
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Carmichael, California, United States, 95608
        • Mercy San Juan Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Memorial Health University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University
      • Rockford, Illinois, United States, 61103
        • Javon Bea Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Healthcare
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Medical Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Missouri
      • St Louis, Missouri, United States, 63110
        • St. Louis University
    • New York
      • Buffalo, New York, United States, 14075
        • University of Buffalo
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Toledo, Ohio, United States, 43604
        • Mercy Health St. Vincent Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 61103
        • Greenville Health System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Tennessee Interventional and Imaging Associates
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee
    • Texas
      • Plano, Texas, United States, 75075
        • Texas Stroke Institute
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Coils
MICRUSFRAME and GALAXY coils
Device: MICRUSFRAME and GALAXY coils
MICRUSFRAME and GALAXY Coils

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occlusion Rate
Time Frame: 12 Months
Occlusion rate at 12 Months post procedure
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1. Packing Density
Time Frame: 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.
From enrollment to end of treatment at 12 months
2. Complete occlusion rate
Time Frame: 12 month
Complete occlusion rate at 12 month follow-up
12 month
3. Recanalization Rate
Time Frame: 12 Months
Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up
12 Months
4. Device related serious adverse events
Time Frame: 12 Months
Any device related serious adverse events will be reported through 12 month follow-up
12 Months
5. Retreatment Rate
Time Frame: 12 Months
Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up
12 Months
6. Modified Rankin Score
Time Frame: 12 Months

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.
12 Months
7. Length of hospital stay
Time Frame: From enrollment to 12 Months
Hospital stay length will be recorded
From enrollment to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cerenovus, Part of DePuy Synthes Products, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reade De Leacy, Mount Sinai Hospital, New York
  • Principal Investigator: Osama Zaidat, Mercy Health St. Vincent Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNV_2017_01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aneurysms

Clinical Trials on MICRUSFRAME and GALAXY coils

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings