Coil Embolization with Different Coil Sizes for Brain Aneurysm
(FEAT Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Overseen byJ D Mocco, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults aged 18-80 with brain aneurysms suitable for endovascular treatment. Candidates must be able to consent, have a Hunt and Hess grade of 0-3, and commit to follow-up visits. Excluded are those with life expectancy under 2 years, previous treatments on the aneurysm, or multiple untreated aneurysms.

Inclusion Criteria

My aneurysm has not been treated with coiling or clipping.

I have a brain aneurysm suitable for treatment without surgery, as decided by my doctors.

The doctor believes the aneurysm can be safely treated with a specific size of platinum coil.

+6 more

Exclusion Criteria

My aneurysm was previously treated with coils or surgery.

I have multiple aneurysms but only one meets the trial's criteria for treatment now.

Inability to obtain informed consent

+2 more

Participant Groups

The study compares two coil embolization techniques in treating cerebral aneurysms: one using standard diameter coils (less than 0.014 inches) and another using larger diameter coils (0.014-0.0155 inches). The goal is to see which results in better angiographic occlusion.

2Treatment groups

Active Control

Group I: Eighteen Coils (0.014-0.0155 inch)Active Control1 Intervention

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.

Group II: Standard Coils (0.014 inch)Active Control1 Intervention

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.