N/A
N=105
Coarctation Of the Aorta Stent Trial
Coarctation of the Aorta
Bottom Line
View on ClinicalTrials.gov: NCT00552812 ↗Enrolled (actual)
105
Serious AEs
1.0%
Results posted
Sep 2014
Primary outcome: Primary: Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months — 30 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stent therapy of aortic coarctation (Device)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Richard E. Ringel
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months |
30 | — |
| SECONDARY Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement |
61; 17 | — |
| SECONDARY Systolic Blood Pressure, Difference Between Upper and Lower Extremities |
29; -1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00552812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.