Aortic Coarctation Treatment with Covered CP Stent™ – COAST II

Covered Cheatham Platinum CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated with Coarctation of the Aorta (COAST II) – Continued Study Access

Protocol Description

This multicenter study is being done to test the application of the Covered CP Stent™ for treatment of coarctation of the aorta (CoA) in which an aneurysm or threat of aneurysm is present. The Covered CP Stent, also known as a covered Cheatham platinum stent, is a metallic wire tube wrapped with a fluoropolymer material. CoA is a narrowing of the aorta, the body’s main blood vessel, and an aneurysm is a weakened part that risks rupture. The initial study, begun in 2010, has achieved its maximum intended enrollment, however the Food and Drug Administration has extended use of the Covered CP Stent to other patients while the initial study patients continue to be followed.

Eligibility Criteria

A physician’s referral is required for this study, which, subject to certain exclusion criteria, is open to children and teens who have CoA and an aneurysm or who are at increased risk of an aneurysm.
Males and Females: Ages 8 to 80

Requirements

Using standard medical practice for this condition, the compressed stent is placed atop a balloon-tipped catheter that will be inserted through the blood vessel to the area of narrowing. Once in place, the stent will be expanded by the balloon and the catheter removed. 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

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