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Framing Eighteen Coils in Cerebral Aneurysms Trial — FEAT  

Cerebral Aneurysm Clinical Trial

Official title:
Framing Eighteen Coils in Cerebral Aneurysms Trial: FEAT

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01655784
Study type Interventional
Source Vanderbilt University Medical Center
Contact
Status Active, not recruiting
Phase N/A
Start date December 4, 2012
Completion date May 2024
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