search
Back to results

Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)

Primary Purpose

Cerebral Aneurysm

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coil Embolization with larger Diameter Coils
Coil Embolization with Standard Diameter Coils
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Aneurysm focused on measuring aneurysm, intracranial aneurysm, cerebral aneurysm, intracranial embolization, aneurysm embolization, intracranial coil, eighteen coils, bare platinum coils, GDC Coil, Target Coil

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSF-Fresno, Community Regional Medical Center
  • Radiology Imaging Associates
  • Colorado Neurological Institute
  • University of Florida
  • University of South Florida - Tampa General
  • University of Kentucky
  • University of Massachusetts Medical School
  • University of Mississippi
  • University of Buffalo
  • Icahn School of Medicine at Mount Sinai
  • Stony Brook University
  • Wake Forest Baptist Health
  • Mayfield Clinic
  • Ohio State University
  • Medical Center of South Carolina
  • Prisma Health
  • Tennessee Interventional Associates - Erlanger
  • Fort Sanders Regional Medical Center
  • University of Tennessee Medical Center - Knoxville
  • Methodist University Hospital
  • Vanderbilt University Medical Center
  • University of Texas - Southwestern
  • Virginia Commonwealth University
  • West Virginia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eighteen Coils (0.014-0.0155 inch)

Standard Coils (0.014 inch)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Morbidity
Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.
Packing Density
Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
Clinical Outcome
Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.
Re-hemorrhage and Re-treatment Rates
Re-hemorrhage rates will be tracked and recorded during both follow-up time points.
Mortality
Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.
Retreatment
Retreatment rates will be tracked and recorded during both follow-up time points.

Full Information

First Posted
July 20, 2012
Last Updated
September 18, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
Stryker Neurovascular
search

1. Study Identification

Unique Protocol Identification Number
NCT01655784
Brief Title
Framing Eighteen Coils in Cerebral Aneurysms Trial
Acronym
FEAT
Official Title
Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Stryker Neurovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: Treatment related morbidity and mortality, as measured by the NIH stroke scale. Packing density as measured by volumetric filling of the aneurysm. Clinical outcome at 3-6 and 12-18 months post-coiling, as measured by the modified Rankin scale. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm
Keywords
aneurysm, intracranial aneurysm, cerebral aneurysm, intracranial embolization, aneurysm embolization, intracranial coil, eighteen coils, bare platinum coils, GDC Coil, Target Coil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
651 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eighteen Coils (0.014-0.0155 inch)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Coils (0.014 inch)
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Coil Embolization with larger Diameter Coils
Other Intervention Name(s)
Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm Coils
Intervention Description
Eighteen Coils placed in cerebral aneurysm
Intervention Type
Procedure
Intervention Name(s)
Coil Embolization with Standard Diameter Coils
Other Intervention Name(s)
Eighteen Coils, Cerebral Aneurysm Embolization, Aneurysm Coils
Intervention Description
Cerebral aneurysms will be embolized with standard diameter coils.
Primary Outcome Measure Information:
Title
Occlusion Rate
Description
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.
Time Frame
12-18 Month Follow-up
Secondary Outcome Measure Information:
Title
Morbidity
Description
Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.
Time Frame
Entire Study Duration (from signed research consent until 12-18 month follow-up complete)
Title
Packing Density
Description
Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
Time Frame
Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)
Title
Clinical Outcome
Description
Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.
Time Frame
3-6 Month Follow-up and 12-18 Month Follow-up
Title
Re-hemorrhage and Re-treatment Rates
Description
Re-hemorrhage rates will be tracked and recorded during both follow-up time points.
Time Frame
3-6 Month Follow-up and 12-18 Month Follow-up
Title
Mortality
Description
Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.
Time Frame
Entire Study Duration (from study procedure until 12-18 month follow-up)
Title
Retreatment
Description
Retreatment rates will be tracked and recorded during both follow-up time points.
Time Frame
3-6 Month Follow-up and 12-18 Month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular treating team (neurointerventionist and/or neurosurgeon). The neurointerventionist feels that the aneurysm can be safely treated with either using, or not using, a 0.015-0.0155" platinum coil. Patients are 18-80 years of age (inclusive). Patient must be Hunt and Hess grade 0 to 3. 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. Aneurysm 6-14 mm in maximum diameter. 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. The patient has not been previously randomized into this trial or another related ongoing trial. The aneurysm has not been previously treated by coiling or clipping. Exclusion Criteria: 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). Target aneurysm has had previous coil treatment or has been surgically clipped. Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage. Inability to obtain informed consent. Medical or surgical co-morbidity such that the patient's life expectancy is less than 2 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J D Mocco, MD, MS
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF-Fresno, Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Radiology Imaging Associates
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of South Florida - Tampa General
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Massachusetts Medical School
City
North Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Mayfield Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Medical Center of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Tennessee Interventional Associates - Erlanger
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Fort Sanders Regional Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
University of Tennessee Medical Center - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
University of Texas - Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.vumc.org/neurosurgerydept/welcome
Description
Vanderbilt University Medical Center-Department of Neurological Surgery

Learn more about this trial

Framing Eighteen Coils in Cerebral Aneurysms Trial

We'll reach out to this number within 24 hrs