Framing Eighteen Coils in Cerebral Aneurysms Trial



Status:Recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 80
Updated:2/24/2019
Start Date:August 2012
End Date:January 2021
Contact:Stephanie A Smith, M.A.
Email:Stephanie.Anne.Smith@vumc.org
Phone:6159360815

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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.

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.

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.
We found this trial at
25
sites
Winston-Salem, North Carolina 27157
Principal Investigator: Stacey Q Wolfe, MD
Phone: 336-716-3842
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Adam Polifka, MD
Phone: 352-273-7773
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1924 Alcoa Highway
Knoxville, Tennessee 37920
Principal Investigator: Andrew Ferrell, MD
Phone: 865-305-5651
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Knoxville, TN
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Michael Froehler, MD, PhD
Phone: 615-936-0815
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Aditya Pandey, MD
Phone: 734-647-5436
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Buffalo, New York 14215
Principal Investigator: Adnan H Siddiqui, MD, Ph.D.
Phone: 716-218-1000
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Charleston, South Carolina
Principal Investigator: Raymond Turner, MD, FAANS
Phone: 843-792-7971
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Chattanooga, Tennessee 37403
Principal Investigator: Harris Hawk, MD
Phone: 423-778-6216
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Cincinnati, Ohio 45219
Principal Investigator: Andrew Ringer, MD
Phone: 513-558-3590
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Ciaran Powers, MD, PhD
Phone: 614-685-8622
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dallas, Texas 75390
Principal Investigator: Babu Welch, MD
Phone: 214-648-7815
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Englewood, Colorado
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Englewood, Colorado 80112
Principal Investigator: Donald Frei, MD
Phone: 720-493-3403
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Fresno, California 93701
Principal Investigator: Amir Khan, MD
Phone: 559-499-6636
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Jackson, Mississippi 39216
Principal Investigator: Gustavo Luzardo, MD
Phone: 601-815-3605
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800 Prudential Drive
Jacksonville, Florida 32207
Principal Investigator: Eric Sauvageau, MD
Phone: 904-398-0125
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1924 Alcoa Highway
Knoxville, Tennessee 37916
Principal Investigator: Keith Woodward, MD
Phone: 865-541-2925
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Justin Fraser, MD
Phone: 859-323-0616
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Memphis, Tennessee 38120
Principal Investigator: Adam Arthur, MD, MPH
Phone: 901-259-5316
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Morgantown, West Virginia
Principal Investigator: Ansaar Rai, MD
Phone: 304-598-6930
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Johanna Fifi, MD
Phone: 212-241-6008
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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55 North Lake Avenue
North Worcester, Massachusetts 01655
Principal Investigator: David Rex, MD
Phone: 774-441-8442
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: John Reavey-Cantwell, MD, MS
Phone: 804-828-9882
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Stony Brook, New York 11794
Principal Investigator: David Fiorella, MD, PhD
Phone: 631-444-8121
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Tampa, Florida 33606
Principal Investigator: Maxim Mokin, MD
Phone: 813-844-4639
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