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Trial record 2 of 20 for:    "Aortic coarctation"

Coarctation Of the Aorta Stent Trial (COAST)

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

Condition Intervention
Coarctation of the Aorta
Device: Stent therapy of aortic coarctation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coarctation Of the Aorta Stent Trial

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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.

Enrollment: 105
Study Start Date: October 2007
Study Completion Date: July 2015
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

Ages Eligible for Study:   8 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00552812

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Richard E. Ringel
Principal Investigator: Richard E Ringel, MD Johns Hopkins University
Principal Investigator: Kathy Jenkins, MD Harvard University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard E. Ringel, MD, Johns Hopkins University Identifier: NCT00552812     History of Changes
Other Study ID Numbers: G060057
Study First Received: October 31, 2007
Results First Received: September 19, 2014
Last Updated: February 14, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Individual patient data is confidential and is not shared.

Keywords provided by Johns Hopkins University:
Aortic Coarctation
Heart Defects, Congenital
Heart Catheterization

Additional relevant MeSH terms:
Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on April 25, 2017