Coarctation Of the Aorta Stent Trial

Coarctation Of the Aorta Stent Trial

The purpose of this study is to determine whether Cheatham Platinum bare metal stents are safe and effective in the treatment of native and recurrent aortic coarctation in selected children, adolescents and adults.

The goals of this study are to provide information that will support labeling of both the CP bare metal and covered stents to treat native and recurrent aortic coarctation in selected children, adolescents and adults. The investigation will have two phases: Phase One will examine the safety and efficacy of the bare metal stent, and will collect information about the covered stent when used as rescue therapy for aortic injuries occurring during bare metal stent procedures.

The aims of the Phase One study are to assess the use of the CP bare metal stent to:

1. provide a reduction equivalent to surgery in arm-leg systolic cuff blood pressure gradient 12 months after dilation and stent implantation, in comparison to the pre-dilation gradient;
2. accomplish gradient relief with a shorter number of days in hospital than surgery;
3. accomplish gradient relief with a rate of occurrence of serious procedure-related adverse events occurring within 30 days of dilation that is equivalent to surgery; and
4. accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.

Inclusion Criteria:

• Native or recurrent aortic coarctation
• Weight greater than or equal to 35 kg
• Noninvasive, arm-leg cuff systolic blood pressure difference or catheter measured systolic coarctation gradient greater than or equal to 20 mmHg

Exclusion Criteria:

• Age > 60 years
• Connective tissue disorders, including Marfan syndrome and other genetic syndromes such as Turner syndrome and Noonan syndrome
• Inflammatory aortitis
• Bloodstream infection, including endocarditis
• Pregnancy
• Aortic aneurysm
• Prior stent placement
• Adults lacking capacity to consent
• Foster children and/or wards of the court