Coarctation Of the Aorta Stent Trial

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Stent therapy of aortic coarctation	Stent therapy of aortic coarctation	Stenting of aortic coarctation

Primary Outcome Measures

Name	Time	Method
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months	12 months	Noninvasive systolic blood pressures are measured in the arms and legs at baseline and 12 month follow-up. The difference between these measurements are calculated. The difference between systolic arm and leg blood pressures decreased by 30 ± 22 mmHg (n=90)

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure, Difference Between Upper and Lower Extremities	Baseline and 12 months	Measurement of difference between upper and lower extremities by noninvasive, automated measurement of four quadrant Systolic Blood Pressure. Comparison between baseline and 12 month follow up.
Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement	Baseline and 12 months	Noninvasive Blood pressure is assessed at baseline and 12 months. The number of patients with a Systolic Blood Pressure \> 95th Percentile for Age and Gender is recorded at Baseline (n=105) and compared to 12 month follow up (n=92).