Coarctation Of the Aorta Stent Trial (COAST)
|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|
- Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]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)
- Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]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).
- Systolic Blood Pressure, Difference Between Upper and Lower Extremities [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||July 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|