Coarctation Of the Aorta Stent Trial (COAST)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Coarctation Of the Aorta Stent Trial|
- Reduction of Arm-leg Systolic Blood Pressure Difference [ Time Frame: 12 months ] [ Designated as safety issue: No ]Reduction in systolic blood pressure gradient, baseline to 12 month follow-up 30 ± 22 mmHg (n=90)
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Stent therapy of aortic coarctation
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.
Other Name: Cheatham-Platinum Stent
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:
- 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;
- accomplish gradient relief with a shorter number of days in hospital than surgery;
- 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
- accomplish gradient relief with a rate of occurrence of post-procedural paradoxical hypertension that is lower than surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552812
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Richard E Ringel, MD||Johns Hopkins University|
|Principal Investigator:||Kathy Jenkins, MD||Harvard University|