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Trial record 1 of 1 for:    CNV_2017_01
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A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms (STERLING)

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ClinicalTrials.gov Identifier: NCT03642639
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 23, 2018
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Coils
MICRUSFRAME and GALAXY coils
Device: MICRUSFRAME and GALAXY coils
MICRUSFRAME and GALAXY Coils




Primary Outcome Measures :
  1. Occlusion Rate [ Time Frame: 12 Months ]
    Occlusion rate at 12 Months post procedure


Secondary Outcome Measures :
  1. 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.

  2. 2. Complete occlusion rate [ Time Frame: 12 month ]
    Complete occlusion rate at 12 month follow-up

  3. 3. Recanalization Rate [ Time Frame: 12 Months ]
    Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up

  4. 4. Device related serious adverse events [ Time Frame: 12 Months ]
    Any device related serious adverse events will be reported through 12 month follow-up

  5. 5. Retreatment Rate [ Time Frame: 12 Months ]
    Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up

  6. 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.

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



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642639


Contacts
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Contact: Lillian Ma 9494668021 lma46@its.jnj.com

Locations
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United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Principal Investigator: Reade De Leacy, MD         
United States, Ohio
Mercy Health St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43604
Principal Investigator: Osama Zaidat, MD, MS         
Belgium
Az Groeninge Recruiting
Kortrijk, Belgium
Principal Investigator: Olivier Francois, MD         
Sponsors and Collaborators
Cerenovus, Part of DePuy Synthes Products, Inc.
Investigators
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Principal Investigator: Reade De Leacy Mount Sinai Hospital, New York
Principal Investigator: Osama Zaidat Mercy Health St. Vincent Hospital
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Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
ClinicalTrials.gov Identifier: NCT03642639    
Other Study ID Numbers: CNV_2017_01
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021

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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:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases