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Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (COASTII)

This study has been completed.
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Richard E. Ringel, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01278303
First received: August 2, 2010
Last updated: February 15, 2016
Last verified: February 2016
Results First Received: April 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Aortic Coarctation
Intervention: Device: Treatment of Aortic Wall Injury

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment of Aortic Wall Injury

Repair of aortic wall injury with covered CP Stents

Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.


Participant Flow:   Overall Study
    Treatment of Aortic Wall Injury
STARTED   82 
COMPLETED   82 
NOT COMPLETED   0 



  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
Treatment of Aortic Wall Injury

Repair of aortic wall injury with covered CP Stents

Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.


Baseline Measures
   Treatment of Aortic Wall Injury 
Overall Participants Analyzed 
[Units: Participants]
 82 
Age 
[Units: Years]
Median (Full Range)
 18 
 (6 to 67) 
Age 
[Units: Participants]
 
<=18 years   41 
Between 18 and 65 years   38 
>=65 years   3 
Gender 
[Units: Participants]
 
Female   30 
Male   52 
Region of Enrollment 
[Units: Participants]
 
United States   82 


  Outcome Measures
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1.  Primary:   Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening   [ Time Frame: Baseline and 12 months ]

2.  Secondary:   Secondary Efficacy Outcomes - 1 Year   [ Time Frame: 1 years ]

3.  Secondary:   Secondary Safety Outcomes - Adverse Events   [ Time Frame: 2 years ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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



Responsible Party: Richard E. Ringel, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01278303     History of Changes
Other Study ID Numbers: G060057a
RFD003898A ( Other Grant/Funding Number: Food and Drug Administration )
Study First Received: August 2, 2010
Results First Received: April 8, 2015
Last Updated: February 15, 2016
Health Authority: United States: Food and Drug Administration