Coarctation Of the Aorta Stent Trial (COAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Richard E. Ringel, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00552812
First received: October 31, 2007
Last updated: September 19, 2014
Last verified: September 2014
  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 therapy of aortic coarctation

Study Type: Interventional
Study Design: 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:


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 ]
    Reduction in systolic blood pressure gradient, baseline to 12 month follow-up 30 ± 22 mmHg (n=90)


Enrollment: 105
Study Start Date: October 2007
Estimated Study Completion Date: December 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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Richard E. Ringel
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 E. Ringel, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00552812     History of Changes
Other Study ID Numbers: G060057
Study First Received: October 31, 2007
Results First Received: September 19, 2014
Last Updated: September 19, 2014
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 October 19, 2014