Coarctation Of the Aorta Stent Trial (COAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard E. Ringel, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00552812
First received: October 31, 2007
Last updated: February 14, 2016
Last verified: February 2016

October 31, 2007
February 14, 2016
October 2007
December 2012   (final data collection date for primary outcome measure)
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)
Reduction of Arm-leg Systolic Blood Pressure Difference [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00552812 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Coarctation Of the Aorta Stent Trial
Coarctation Of the Aorta Stent Trial
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coarctation of the Aorta
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
Experimental: Stent therapy of aortic coarctation
Stenting of aortic coarctation
Intervention: Device: Stent therapy of aortic coarctation
Meadows J, Minahan M, McElhinney DB, McEnaney K, Ringel R; COAST Investigators*. Intermediate Outcomes in the Prospective, Multicenter Coarctation of the Aorta Stent Trial (COAST). Circulation. 2015 May 12;131(19):1656-64. doi: 10.1161/CIRCULATIONAHA.114.013937. Epub 2015 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
July 2015
December 2012   (final data collection date for primary outcome measure)

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
Both
8 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00552812
G060057
Yes
No
Individual patient data is confidential and is not shared.
Richard E. Ringel, Johns Hopkins University
Richard E. Ringel
Not Provided
Principal Investigator: Richard E Ringel, MD Johns Hopkins University
Principal Investigator: Kathy Jenkins, MD Harvard University
Johns Hopkins University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP