Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
651 participants
INTERVENTIONAL
2012-12-04
2024-02-19
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Coil Embolization with larger Diameter Coils
Eighteen Coils placed in cerebral aneurysm
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.
Coil Embolization with Standard Diameter Coils
Cerebral aneurysms will be embolized with standard diameter coils.
Interventions
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Coil Embolization with larger Diameter Coils
Eighteen Coils placed in cerebral aneurysm
Coil Embolization with Standard Diameter Coils
Cerebral aneurysms will be embolized with standard diameter coils.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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.
18 Years
80 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Vanderbilt University Medical Center
OTHER
Responsible Party
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JD Mocco
Associate Professor
Principal Investigators
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J D Mocco, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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UCSF-Fresno, Community Regional Medical Center
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
Stony Brook University
Stony Brook, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Mayfield Clinic
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Medical Center of South Carolina
Charleston, South Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Tennessee Interventional Associates - Erlanger
Chattanooga, Tennessee, United States
Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
University of Tennessee Medical Center - Knoxville
Knoxville, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas - Southwestern
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Vanderbilt University Medical Center-Department of Neurological Surgery
Other Identifiers
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120439
Identifier Type: -
Identifier Source: org_study_id
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