Coarctation of the Aorta
Conditions
Keywords
Aortic Coarctation, Heart Defects, Congenital, Stents, Heart Catheterization
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.
Interventions
DEVICEStent therapy of aortic coarctation
Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Sponsors
Richard E. Ringel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment opened February, 2008 and ended December, 2010
Pre-assignment details
Patients were consented as outpatients, but final selection criteria were assessed in the catheterization laboratory
Participants by arm
| Arm | Count |
|---|---|
| Coarctation Stenting Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation. | 105 |
| Total | 105 |
Baseline characteristics
| Characteristic | Coarctation Stenting |
|---|---|
| Age, Categorical <=18 years | 67 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 16 years |
| Region of Enrollment United States | 105 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 105 |
| serious Total, serious adverse events | 1 / 105 |
Outcome results
Primary
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coarctation Stenting | Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months | 30 mmHg | Standard Deviation 22 |
Secondary
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).
Time frame: Baseline and 12 months
Population: Study patients compared at baseline and within the 12 month follow up window: Baseline (n=105) compared to 12 month follow up (n=92)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coarctation Stenting | Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement | Baseline | 61 percentage of participants |
| Coarctation Stenting | Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement | 12 month follow up | 17 percentage of participants |
Secondary
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.
Time frame: Baseline and 12 months
Population: Comparison between baseline(n=105) and 12 month follow up (n=92)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coarctation Stenting | Systolic Blood Pressure, Difference Between Upper and Lower Extremities | Baseline | 29 mmHg | Standard Deviation 17 |
| Coarctation Stenting | Systolic Blood Pressure, Difference Between Upper and Lower Extremities | 12 months | -1 mmHg | Standard Deviation 15 |