Coarctation Of the Aorta Stent Trial

Richard E. Ringel105 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Coarctation of the Aorta

Interventions

Stent therapy of aortic coarctationDEVICE

Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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