Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

This study is currently recruiting participants.
Verified July 2013 by Vanderbilt University
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
JD Mocco, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01655784
First received: July 20, 2012
Last updated: July 23, 2013
Last verified: July 2013

July 20, 2012
July 23, 2013
August 2012
January 2017   (final data collection date for primary outcome measure)
Occlusion Rate [ Time Frame: 12-18 Month Follow-up ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01655784 on ClinicalTrials.gov Archive Site
  • Morbidity [ Time Frame: Entire Study Duration (from signed research consent until 12-18 month follow-up complete) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Costs of each arm will be compared.
  • Mortality [ Time Frame: Entire Study Duration (from study procedure until 12-18 month follow-up) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Retreatment rates will be tracked and recorded during both follow-up time points.
Same as current
Not Provided
Not Provided
 
Framing Eighteen Coils in Cerebral Aneurysms Trial
Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

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.

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.
  5. Cost of therapy.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cerebral Aneurysm
  • 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
  • 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: 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: Target 360 Standard, Target 360 Soft, Target 360 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
660
June 2017
January 2017   (final data collection date for primary outcome measure)

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 at least 18 years old and less than 80 years of age.
  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 7-14 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.
Both
18 Years to 79 Years
No
Contact: Bree L Burks, RN, BSN 6158757606 Bree.Burks@vanderbilt.edu
United States
 
NCT01655784
120439
Yes
JD Mocco, Vanderbilt University
Vanderbilt University
Stryker Neurovascular
Principal Investigator: J D Mocco, MD, MS Vanderbilt University
Vanderbilt University
July 2013

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