Coarctation Of the Aorta Stent Trial (COAST)
Primary Purpose
Coarctation of the Aorta
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stent therapy of aortic coarctation
Sponsored by
About this trial
This is an interventional treatment trial for Coarctation of the Aorta focused on measuring Aortic Coarctation, Heart Defects, Congenital, Stents, Heart Catheterization
Eligibility 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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stent therapy of aortic coarctation
Arm Description
Stenting of aortic coarctation
Outcomes
Primary Outcome Measures
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00552812
Brief Title
Coarctation Of the Aorta Stent Trial
Acronym
COAST
Official Title
Coarctation Of the Aorta Stent Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard E. Ringel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coarctation of the Aorta
Keywords
Aortic Coarctation, Heart Defects, Congenital, Stents, Heart Catheterization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stent therapy of aortic coarctation
Arm Type
Experimental
Arm Description
Stenting of aortic coarctation
Intervention Type
Device
Intervention Name(s)
Stent therapy of aortic coarctation
Other Intervention Name(s)
Cheatham-Platinum Stent
Intervention Description
Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
Primary Outcome Measure Information:
Title
Change in Difference Between Arm and Leg Systolic Blood Pressure From Baseline to 12 Months
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Systolic Blood Pressure Greater Than the 95th Percentile for Age and Gender 12 Months Post Stent Placement
Description
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).
Time Frame
Baseline and 12 months
Title
Systolic Blood Pressure, Difference Between Upper and Lower Extremities
Description
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.
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E Ringel, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathy Jenkins, MD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data is confidential and is not shared.
Citations:
PubMed Identifier
34039015
Citation
Holzer RJ, Gauvreau K, McEnaney K, Watanabe H, Ringel R. Long-Term Outcomes of the Coarctation of the Aorta Stent Trials. Circ Cardiovasc Interv. 2021 Jun;14(6):e010308. doi: 10.1161/CIRCINTERVENTIONS.120.010308. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
25869198
Citation
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.
Results Reference
derived
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Coarctation Of the Aorta Stent Trial
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