Aortic Coarctation Treatment with CP Stent™ – COAST

Protocol Description

This multicenter study is being done to test the application of the CP Stent™, an uncovered platinum-iridium wire stent, also known as the Cheatham platinum stent, for treatment of coarctation of the aorta (CoA). CoA is a narrowing of the aorta, the body’s main blood vessel. The initial study, begun in 2007, has achieved its maximum intended enrollment, however the Food and Drug Administration has extended use of the CP Stent based on certain proven advantages over stainless steel versions, such as compatibility with magnetic resonance imaging and easy visualization via x-ray and fluoroscopy.

Eligibility Criteria

A physician’s referral is required for this study, which is open to children and teens who have native or recurrent CoA.
Males and Females: Ages 8 to 80

Requirements

Using standard medical practice for this condition, a balloon-tipped catheter will be inserted through the blood vessel positioned across the aortic coarctation and inflated with low pressure to stretch the narrowed portion. If the area stretches well enough, the CP Stent will be used and the child will be admitted into the study. Follow-up visits will occur at 1 month, 6 months and annually thereafter for 5 years.
Visits: Requires hospitalization; then, follow-up visits
Duration: 6 years

Status: Open to Enrollment

Source(s) of Support

Johns Hopkins University

Additional Information

Study Description at National Institutes of Health

Primary Investigator

Jacqueline Kreutzer, MD, FACC, FSCAI

Contact Information

For information, please contact:
Kelli Shepler, CRC
412-692-6061
or
Jane Luce, MPH, CHES
412-692-6762