Coarctation Of the Aorta Stent Trial

Coarctation of the Aorta Clinical Trial

— COAST  

Official title:

Coarctation Of the Aorta Stent Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552812
• Other study ID #: G060057
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: February 14, 2016
• Start date: October 2007
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of the Aorta

Intervention

Device:
• Stent therapy of aortic coarctation
Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Richard E. Ringel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	12 months	No
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).	Baseline and 12 months	No
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.	Baseline and 12 months	No