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Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

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ClinicalTrials.gov Identifier: NCT01655784
Recruitment Status : Recruiting
First Posted : August 2, 2012
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
JD Mocco, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE August 2, 2012
Last Update Posted Date February 22, 2019
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2012)
Occlusion Rate [ Time Frame: 12-18 Month Follow-up ]
Occlusion rate: Angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01655784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
  • Morbidity [ Time Frame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete) ]
    Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.
  • Packing Density [ Time Frame: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed) ]
    Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
  • Clinical Outcome [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.
  • Re-hemorrhage and Re-treatment Rates [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Re-hemorrhage rates will be tracked and recorded during both follow-up time points.
  • Mortality [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ]
    Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.
  • Retreatment [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Retreatment rates will be tracked and recorded during both follow-up time points.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2012)
  • Morbidity [ Time Frame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete) ]
    Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.
  • Packing Density [ Time Frame: Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed) ]
    Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
  • Clinical Outcome [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.
  • Re-hemorrhage and Re-treatment Rates [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Re-hemorrhage rates will be tracked and recorded during both follow-up time points.
  • Cost [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ]
    Costs of each arm will be compared.
  • Mortality [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ]
    Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.
  • Retreatment [ Time Frame: 3-6 Month Follow-up and 12-18 Month Follow-up ]
    Retreatment rates will be tracked and recorded during both follow-up time points.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Framing Eighteen Coils in Cerebral Aneurysms Trial
Official Title  ICMJE Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
Brief Summary

This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter).

Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.

Detailed Description

Primary Study Objective: Occlusion rate: angiographic occlusion, improvement or no change in the post-coiling appearance of the aneurysm as judged by an independent core lab on follow-up angiography at 12-18 months after endovascular embolization.

Secondary Objectives:

  1. Treatment related morbidity and mortality, as measured by the NIH stroke scale.
  2. Packing density as measured by volumetric filling of the aneurysm.
  3. Clinical outcome at 3-6 and 12-18 months post-coiling, as measured by the modified Rankin scale.
  4. Re-hemorrhage and re-treatment rates.

Study Design: FEAT will be a prospective, randomized trial comparing the utilization of 0.014-0.0155" coils versus smaller diameter coils in mid-sized aneurysm treatment. The 0.014-0.0155" bare platinum coils (Stryker, Natick, MA) are FDA-approved and in common use at institutions in this country and across the world. Patients will be enrolled who meet the inclusion criteria and consent to participate. Patients will be randomly assigned by a central web-based system in a 1:1 manner to either the framing coil treatment or the non-framing coil treatment. Data on each patient will be collected at the time of enrollment and treatment, and at first and second follow-up visits.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Aneurysm
Intervention  ICMJE
  • Procedure: Coil Embolization with larger Diameter Coils
    Eighteen Coils placed in cerebral aneurysm
    Other Names:
    • Eighteen Coils
    • Cerebral Aneurysm Embolization
    • Aneurysm Coils
  • Procedure: Coil Embolization with Standard Diameter Coils
    Cerebral aneurysms will be embolized with standard diameter coils.
    Other Names:
    • Eighteen Coils
    • Cerebral Aneurysm Embolization
    • Aneurysm Coils
Study Arms
  • Active Comparator: Eighteen Coils (0.014-0.0155 inch)
    Subjects who randomize to this arm will receive larger diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target XL 360 Standard, Target XL 360 Soft, Target XL 360 Helical, GDC-18 360 Standard, GDC-18 3D, GDC-18 2D, GDC-18 Soft, and/or 0.014-0.0155 inch diameter bare platinum intracranial coils.
    Intervention: Procedure: Coil Embolization with larger Diameter Coils
  • Active Comparator: Standard Coils (0.014 inch)
    Subjects who randomize to this arm will receive the standard diameter bare platinum coils for treatment of their cerebral aneurysm. Subjects in this arm could receive a combination of the following protocol approved intracranial coils depending on the phase: Target 360 Standard, Target 360 Soft, Target 360 Ultra, Target 360 NANO, Target 360 Helical Ultra, GDC-10 360 Standard SR, GDC-10 360 Soft SR, GDC-10 UltraSoft, GDC-10 3D, GDC-10 2D, GDC-10 Soft 2D SR, GDC-10 Soft SR, GDC-10 Soft, and/or any additional 0.014 inch or less diameter bare platinum intracranial coils.
    Intervention: Procedure: Coil Embolization with Standard Diameter 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 1, 2012)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon).
  2. The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.015-0.0155" platinum coil.
  3. Patients are 18-80 years of age (inclusive).
  4. Patient must be Hunt and Hess grade 0 to 3.
  5. Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
  6. Aneurysm 6-14 mm in maximum diameter.
  7. Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at 3-6 months and 12-18 months after endovascular treatment.
  8. The patient has not been previously randomized into this trial or another related ongoing trial.
  9. The aneurysm has not been previously treated by coiling or clipping.

Exclusion Criteria:

  1. Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the FEAT inclusion criteria (ie - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses).
  2. Target aneurysm has had previous coil treatment or has been surgically clipped.
  3. Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage.
  4. Inability to obtain informed consent.
  5. Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Stephanie A Smith, M.A. 6159360815 Stephanie.Anne.Smith@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01655784
Other Study ID Numbers  ICMJE 120439
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party JD Mocco, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Stryker Neurovascular
Investigators  ICMJE
Principal Investigator: J D Mocco, MD, MS Icahn School of Medicine at Mount Sinai
PRS Account Vanderbilt University Medical Center
Verification Date February 2019

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