Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Status: Completed
Location: See all (24) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UCSF-Fresno, Community Regional Medical Center
Fresno
Colorado
Colorado Neurological Institute
Englewood
Radiology Imaging Associates
Englewood
Florida
University of Florida
Gainesville
University of South Florida - Tampa General
Tampa
Kentucky
University of Kentucky
Lexington
Massachusetts
University of Massachusetts Medical School
North Worcester
Mississippi
University of Mississippi
Jackson
North Carolina
Wake Forest Baptist Health
Winston-salem
New York
University of Buffalo
Buffalo
Icahn School of Medicine at Mount Sinai
New York
Stony Brook University
Stony Brook
Ohio
Mayfield Clinic
Cincinnati
Ohio State University
Columbus
South Carolina
Medical Center of South Carolina
Charleston
Prisma Health
Greenville
Tennessee
Tennessee Interventional Associates - Erlanger
Chattanooga
Fort Sanders Regional Medical Center
Knoxville
University of Tennessee Medical Center - Knoxville
Knoxville
Methodist University Hospital
Memphis
Vanderbilt University Medical Center
Nashville
Texas
University of Texas - Southwestern
Dallas
Virginia
Virginia Commonwealth University
Richmond
West Virginia
West Virginia University Hospital
Morgantown
Time Frame
Start Date: 2012-12-04
Completion Date: 2024-02-19
Participants
Target number of participants: 651
Treatments
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.
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.
Sponsors
Collaborators: Stryker Neurovascular
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov