Coarctation Of the Aorta Stent Trial - Full Text View

Coarctation Of the Aorta Stent Trial (COAST)

This study is enrolling participants by invitation only.

First Received: October 31, 2007 No Changes Posted

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00552812

Purpose

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 enlargement of aortic coarctation

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Coarctation Of the Aorta Stent Trial

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Reduction of arm-leg systolic blood pressure difference [ Time Frame: 12 months ]

Estimated Enrollment:	105
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2012

Intervention Details:

Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Eligibility

Ages Eligible for Study:	8 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552812

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:	Richard E Ringel, MD	Johns Hopkins University
Principal Investigator:	Kathy Jenkins, MD	Harvard University

More Information

No publications provided

Study ID Numbers:	G060057
Study First Received:	October 31, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00552812 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Aortic Coarctation
Heart Defects, Congenital
Stents
Heart Catheterization

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

Congenital Abnormalities
Heart Defects, Congenital
Aortic Coarctation

ClinicalTrials.gov processed this record on February 08, 2010