Framing Eighteen Coils in Cerebral Aneurysms Trial (FEAT)
Cerebral Aneurysm
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
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.
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
Active Comparator
Active Comparator
Eighteen Coils (0.014-0.0155 inch)
Standard Coils (0.014 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.
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.