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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.

Tracking Information
First Submitted Date  ICMJE July 11, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE August 23, 2018
Estimated Primary Completion Date January 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
Occlusion Rate [ Time Frame: 12 Months ]
Occlusion rate at 12 Months post procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03642639 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • 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. Complete occlusion rate [ Time Frame: 12 month ]
    Complete occlusion rate at 12 month follow-up
  • 3. Recanalization Rate [ Time Frame: 12 Months ]
    Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up
  • 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. Retreatment Rate [ Time Frame: 12 Months ]
    Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up
  • 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. Length of hospital stay [ Time Frame: From enrollment to 12 Months ]
    Hospital stay length will be recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
Official Title  ICMJE 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
Brief Summary A post-market registry evaluating ruptured/unruptured aneurysms treated exclusively with Spectra Galaxy and Spectra Micrusframe 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 exclusively with Spectra Galaxy and Spectra Micrusframe coils
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aneurysms
Intervention  ICMJE Device: Spectra Micrusframe and Spectra Galaxy coils
Spectra MICRUSFRAME and Spectra GALAXY Coils
Study Arms Coils
Spectra Micrusframe and Spectra Galaxy coils
Intervention: Device: Spectra Micrusframe and Spectra Galaxy coils
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 21, 2018)
850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date January 28, 2022
Estimated Primary Completion Date January 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Lillian Ma 9494668021 lma46@its.jnj.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03642639
Other Study ID Numbers  ICMJE CNV_2017_01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Cerenovus, Part of DePuy Synthes Products, Inc.
Study Sponsor  ICMJE Cerenovus, Part of DePuy Synthes Products, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Reade De Leacy Mount Sinai Hospital, New York
Principal Investigator: Osama Zaidat Mercy Health St. Vincent Hospital
PRS Account Cerenovus, Part of DePuy Synthes Products, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP