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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
651
Eighteen Coils placed in cerebral aneurysm
Cerebral aneurysms will be embolized with standard diameter coils.
UCSF-Fresno, Community Regional Medical Center
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.
Time frame: 12-18 Month Follow-up
Morbidity
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)
Packing Density
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)
Clinical Outcome
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
Re-hemorrhage and Re-treatment Rates
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
Mortality
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)
Retreatment
Retreatment rates will be tracked and recorded during both follow-up time points.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fresno, California, United States
Radiology Imaging Associates
Englewood, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of South Florida - Tampa General
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
University of Massachusetts Medical School
North Worcester, Massachusetts, United States
University of Mississippi
Jackson, Mississippi, United States
University of Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
...and 14 more locations
Time frame: 3-6 Month Follow-up and 12-18 Month Follow-up