Framing Eighteen Coils in Cerebral Aneurysms Trial

Not Applicable

Completed

• Conditions: Cerebral Aneurysm
• Interventions: Procedure: Coil Embolization with Standard Diameter Coils; Procedure: Coil Embolization with larger Diameter Coils

• Registration Number: NCT01655784
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-02
• Study Start: 2012-12-04
• Primary Completion: 2024-02-19
• Study Completion: 2024-02-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 651

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Coils (0.014 inch)	Coil Embolization with Standard Diameter 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.
Eighteen Coils (0.014-0.0155 inch)	Coil Embolization with larger Diameter Coils	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.

Primary Outcome Measures

Name	Time	Method
Occlusion Rate	12-18 Month Follow-up	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 Outcome Measures

Name	Time	Method
Morbidity	Entire Study Duration (from signed research consent until 12-18 month follow-up complete)	Morbidity will be measured by the NIH Stroke Scale and tracked regardless of whether it is related to the study procedure.
Re-hemorrhage and Re-treatment Rates	3-6 Month Follow-up and 12-18 Month Follow-up	Re-hemorrhage rates will be tracked and recorded during both follow-up time points.
Mortality	Entire Study Duration (from study procedure until 12-18 month follow-up)	Mortality will be tracked throughout the study and recorded regardless of whether it is related to treatment.
Clinical Outcome	3-6 Month Follow-up and 12-18 Month Follow-up	Clinical outcome at both follow-up time points will be measured by the modified Rankin Scale.
Packing Density	Post-Procedure (images taken during the procedure immediately after the coils are placed will be assessed)	Packing density will be measured by volumetric filling of the aneurysm by reviewing post-op angiographic films.
Retreatment	3-6 Month Follow-up and 12-18 Month Follow-up	Retreatment rates will be tracked and recorded during both follow-up time points.

Trial Locations

Locations (24)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

UCSF-Fresno, Community Regional Medical Center; 🇺🇸 Fresno, California, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States

Colorado Neurological Institute; 🇺🇸 Englewood, Colorado, United States

Tennessee Interventional Associates - Erlanger; 🇺🇸 Chattanooga, Tennessee, United States

University of Buffalo; 🇺🇸 Buffalo, New York, United States

Radiology Imaging Associates; 🇺🇸 Englewood, Colorado, United States

Fort Sanders Regional Medical Center; 🇺🇸 Knoxville, Tennessee, United States

University of Texas - Southwestern; 🇺🇸 Dallas, Texas, United States

Methodist University Hospital; 🇺🇸 Memphis, Tennessee, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Mayfield Clinic; 🇺🇸 Cincinnati, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Massachusetts Medical School; 🇺🇸 North Worcester, Massachusetts, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

University of South Florida - Tampa General; 🇺🇸 Tampa, Florida, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

University of Mississippi; 🇺🇸 Jackson, Mississippi, United States

University of Tennessee Medical Center - Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Medical Center of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States