Coarctation Of the Aorta Stent Trial

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