Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Aneurysm
• Intervention / Treatment: Procedure: Coil Embolization with larger Diameter Coils; Procedure: Coil Embolization with Standard 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: Interventional
• Enrollment (Actual): 651
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93701
      • UCSF-Fresno, Community Regional Medical Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
    • Englewood, Colorado, United States, 80112
      • Radiology Imaging Associates
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida - Tampa General
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky
  • Massachusetts
    • North Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Mayfield Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical Center of South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Tennessee Interventional Associates - Erlanger
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center - Knoxville
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Regional Medical Center
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas - Southwestern
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion Rate	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.	12-18 Month Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.	Entire Study Duration (from signed research consent until 12-18 month follow-up complete)
Packing Density	Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.	Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)
Clinical Outcome	Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.	3-6 Month Follow-up and 12-18 Month Follow-up
Re-hemorrhage and Re-treatment Rates	Re-hemorrhage rates will be tracked and recorded during both follow-up time points.	3-6 Month Follow-up and 12-18 Month Follow-up
Mortality	Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.	Entire Study Duration (from study procedure until 12-18 month follow-up)
Retreatment	Retreatment rates will be tracked and recorded during both follow-up time points.	3-6 Month Follow-up and 12-18 Month Follow-up

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Stryker Neurovascular
• Investigators: Principal Investigator: J D Mocco, MD, MS, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

Helpful Links

• Vanderbilt University Medical Center-Department of Neurological Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2012
• Primary Completion (Actual): February 19, 2024
• Study Completion (Actual): February 19, 2024

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimated): August 2, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: aneurysm; cerebral aneurysm; intracranial aneurysm; aneurysm embolization; intracranial embolization; intracranial coil; eighteen coils; bare platinum coils; GDC Coil; Target Coil
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 120439