Coarctation Of the Aorta Stent Trial

Study Overview
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Brief Summary
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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
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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: 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; accomplish gradient relief with a shorter number of days in hospital than surgery; 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 accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.

Official Title
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Coarctation Of the Aorta Stent Trial

Conditions
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Coarctation of the Aorta

Intervention / Treatment
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* Device: Stent therapy of aortic coarctation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent therapy of aortic coarctation<br>Stenting of aortic coarctation | Device: Stent therapy of aortic coarctation<br>* Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.<br>* Other names: Cheatham-Platinum Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement | 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). | Baseline and 12 months | 
| Systolic Blood Pressure, Difference Between Upper and Lower Extremities | 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. | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Aortic Coarctation, Heart Defects, Congenital, Heart Catheterization