Clinical trial NCT00552812: Coarctation Of the Aorta Stent Trial
Official title: Coarctation Of the Aorta Stent Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coarctation of the Aorta
Keywords: Aortic Coarctation
Heart Defects, Congenital
Stents
Heart Catheterization
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement
timeFrame: Baseline and 12 months
measure: Systolic Blood Pressure, Difference Between Upper and Lower Extremities
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Richard E Ringel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Kathy Jenkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holzer RJ, Gauvreau K, McEnaney K, Watanabe H, Ringel R. Long-Term Outcomes of the Coarctation of the Aorta Stent Trials. Circ Cardiovasc Interv. 2021 Jun;14(6):e010308. doi: 10.1161/CIRCINTERVENTIONS.120.010308. Epub 2021 May 27.
citation: Meadows J, Minahan M, McElhinney DB, McEnaney K, Ringel R; COAST Investigators*. Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST). Circulation. 2015 May 12;131(19):1656-64. doi: 10.1161/CIRCULATIONAHA.114.013937. Epub 2015 Apr 13.