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

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ClinicalTrials.gov Identifier: NCT03642639
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

Brief Summary:
A post-market registry evaluating ruptured/unruptured aneurysms treated exclusively with Spectra Galaxy and Spectra Micrusframe coils

Condition or disease Intervention/treatment Phase
Aneurysms Device: Spectra Micrusframe and Spectra 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 exclusively with Spectra Galaxy and Spectra Micrusframe coils

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
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 for the Endovascular Treatment of Intracranial Aneurysms
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : January 29, 2021
Estimated Study Completion Date : January 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Coils
Spectra Micrusframe and Spectra Galaxy coils
Device: Spectra Micrusframe and Spectra Galaxy coils
Spectra MICRUSFRAME and Spectra 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. Patients in whom the planned procedure includes non Cerenovus coils
  2. Pre-planned staged procedure
  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
Contact: Lillian Ma 9494668021 lma46@its.jnj.com

Locations
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         
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

Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
ClinicalTrials.gov Identifier: NCT03642639     History of Changes
Other Study ID Numbers: CNV_2017_01
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases