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

N/A

Waitlist Available

Led By J D Mocco, MD, MS

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 month follow-up and 12-18 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the outcomes of two different coil sizes for embolization. The hypothesis is that the larger coils will be more effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, coil embolization procedures may include risks such as bleeding at the catheter insertion site, infection, allergic reaction to contrast dye used during imaging tests, or more rarely stroke-like symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 month follow-up and 12-18 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 month follow-up and 12-18 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 month follow-up and 12-18 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occlusion Rate

Secondary study objectives

Clinical Outcome

Morbidity

Mortality

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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