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Coil

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

FEAT Trial 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.Check my eligibility
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.See study design
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.

FEAT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occlusion Rate
Secondary outcome measures
Clinical Outcome
Morbidity
Mortality
+3 more

FEAT 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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,541 Total Patients Enrolled
Stryker NeurovascularIndustry Sponsor
34 Previous Clinical Trials
11,588 Total Patients Enrolled
J D Mocco, MD, MSPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this medical experiment?

"This research demands that prospective participators have cerebral aneurysm and be between 18 to 80 years old. At present, 651 patient volunteers are required for this project."

Answered by AI

Are prospective participants able to join this scientific experiment at the moment?

"This clinical trial, which was originally uploaded on August 1st 2012 and last modified on February 14th 2022, has ceased to accept patients. Nevertheless, there are 153 other studies that participants can participate in at this moment."

Answered by AI

How many medical sites are administering this trial currently?

"This clinical trial is running in a total of 21 different medical centres, including Winston-Salem, Greenville and Memphis. To minimise the burden on participants, it is suggested to select the clinic closest to you when enrolling."

Answered by AI

Are geriatric patients eligible to join this experiment?

"The enrolment criteria of this clinical trial demands that participants be between 18 years old and 80 years young."

Answered by AI
~0 spots leftby May 2024