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Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Vanderbilt University Medical Center
Sponsor:
Collaborator:
Stryker Neurovascular
Information provided by (Responsible Party):
JD Mocco, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01655784
First received: July 20, 2012
Last updated: February 27, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention Phase
Cerebral Aneurysm
Procedure: Coil Embolization with larger Diameter Coils
Procedure: Coil Embolization with Standard Diameter Coils
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 660
Study Start Date: August 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Coil Embolization with larger Diameter Coils
Eighteen Coils placed in cerebral aneurysm
Other Names:
  • Eighteen Coils
  • Cerebral Aneurysm Embolization
  • Aneurysm 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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655784

Contacts
Contact: Stephanie A Smith, M.A. 6159360815 Stephanie.Anne.Smith@vanderbilt.edu

  Show 25 Study Locations
Sponsors and Collaborators
Vanderbilt University
Stryker Neurovascular
Investigators
Principal Investigator: J D Mocco, MD, MS Icahn School of Medicine at Mount Sinai
  More Information

Additional Information:
Responsible Party: JD Mocco, J Mocco, MD, MS Lead Principal Investigator, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01655784     History of Changes
Other Study ID Numbers: 120439
Study First Received: July 20, 2012
Last Updated: February 27, 2017

Keywords provided by Vanderbilt University Medical Center:
aneurysm
intracranial aneurysm
cerebral aneurysm
intracranial embolization
aneurysm embolization
intracranial coil
eighteen coils
bare platinum coils
GDC Coil
Target Coil

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

ClinicalTrials.gov processed this record on March 30, 2017