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
Results First Received: September 19, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coarctation of the Aorta
Intervention: Device: Stent therapy of aortic coarctation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment opened February, 2008 and ended December, 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were consented as outpatients, but final selection criteria were assessed in the catheterization laboratory

Reporting Groups
  Description
Coarctation Stenting Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Participant Flow:   Overall Study
    Coarctation Stenting  
STARTED     105 [1]
COMPLETED     85 [2]
NOT COMPLETED     20  
[1] 168 consents, 57 failed cath criteria, 5 met criteria but received covered stent, 1 withdrew consent
[2] Some still remain inside the 2 year follow up window. 2 year follow up data is not yet complete.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Coarctation Stenting Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.

Baseline Measures
    Coarctation Stenting  
Number of Participants  
[units: participants]
  105  
Age  
[units: participants]
 
<=18 years     67  
Between 18 and 65 years     38  
>=65 years     0  
Age  
[units: years]
Median ( Full Range )
  16  
  ( 8 to 52 )  
Gender  
[units: participants]
 
Female     32  
Male     73  
Region of Enrollment  
[units: participants]
 
United States     105  



  Outcome Measures

1.  Primary:   Reduction of Arm-leg Systolic Blood Pressure Difference   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Richard E. Ringel
Organization: Johns Hopkins School of Medicine
phone: 410-614-6745
e-mail: rringel@jhmi.edu


No publications provided


Responsible Party: Richard E. Ringel, 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