An interventional study of Stent therapy of aortic coarctation in Coarctation of the Aorta, sponsored by Richard E. Ringel. Completed at 1 site in United States. Open to participants aged 8 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by Richard E. Ringel · Not applicable, Interventional, and Treatment
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:
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 105 is above the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →This is the only study on the registry with Richard E. Ringel as lead sponsor.
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Exclusion Criteria:
Stenting of aortic coarctation
Device: Stent therapy of aortic coarctation
Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Also known as: Cheatham-Platinum Stent
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
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
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
Recruitment opened February, 2008 and ended December, 2010
| Milestone | Coarctation Stenting |
|---|---|
| Started | 105 |
| Completed | 85 |
| Not completed | 20 |
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)
| mmHg | Coarctation Stenting |
|---|---|
| Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months | 30 ± 22 |
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).
| percentage of participants | Coarctation Stenting |
|---|---|
| Baseline | 61 |
| 12 month follow up | 17 |
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.
| mmHg | Coarctation Stenting |
|---|---|
| Baseline | 29 ± 17 |
| 12 months | -1 ± 15 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coarctation Stenting | — | 1/105 (1%) | 14/105 (13.3%) |
| Event | Coarctation Stenting |
|---|---|
| Abnormal exercise echo test at one yearCardiac disorders | 1/105 |
| Event | Coarctation Stenting |
|---|---|
| Aortic AneurysmCardiac disorders | 5/105 |
| Localized vascular tearVascular disorders | 2/105 |
| Post-procedure hypertensionCardiac disorders | 2/105 |
| Residual aortic obstructionCardiac disorders | 2/105 |
| Stent MalpositionCardiac disorders | 1/105 |
| AV FistulaCardiac disorders | 1/105 |
| Groin HematomaVascular disorders | 1/105 |
| Age, Categorical(Participants) | Coarctation Stenting |
|---|---|
| <=18 years | 67 |
| Between 18 and 65 years | 38 |
| >=65 years | 0 |
| Age, Continuous(years) | Coarctation Stenting |
|---|---|
| Median | 16 (8 to 52) |
| Sex: Female, Male(Participants) | Coarctation Stenting |
|---|---|
| Female | 32 |
| Male | 73 |
| Region of Enrollment(participants) | Coarctation Stenting |
|---|---|
| United States | 105 |
Plan to share: No — Individual patient data is confidential and is not shared.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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