Coarctation Of the Aorta Stent Trial (COAST)
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|ClinicalTrials.gov Identifier: NCT00552812|
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : September 25, 2014
Last Update Posted : March 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coarctation of the Aorta||Device: Stent therapy of aortic coarctation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coarctation Of the Aorta Stent Trial|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||July 2015|
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
- Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months [ Time Frame: 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)
- 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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|