Coarctation Of the Aorta Stent Trial - Full Text View

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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Coarctation Of the Aorta Stent Trial

Resource links provided by NLM:

MedlinePlus related topics: Congenital Heart Defects

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Reduction of arm-leg systolic blood pressure difference [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Coarctation stenting	Device: Stent enlargement 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:

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.

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, 02115

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

Responsible Party:	Richard Ringel, MD, Johns Hopkins Hospital
ClinicalTrials.gov Identifier:	NCT00552812 History of Changes
Other Study ID Numbers:	G060057
Study First Received:	October 31, 2007
Last Updated:	June 24, 2011
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:

Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities

Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 09, 2012