NCT01655784

Framing Eighteen Coils in Cerebral Aneurysms Trial

Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 651 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Coil Embolization with larger Diameter Coils	Eighteen Coils placed in cerebral aneurysm
PROCEDURE	Coil Embolization with Standard Diameter Coils	Cerebral aneurysms will be embolized with standard diameter coils.

Timeline

• Start date: 2012-12-04
• Primary completion: 2024-02-19
• Completion: 2024-02-19
• First posted: 2012-08-02
• Last updated: 2025-02-06

Locations

24 sites across 1 country: United States