A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms (AAA IDE)

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00646048
First received: March 26, 2008
Last updated: January 26, 2011
Last verified: January 2011
Results First Received: June 29, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Abdominal Aortic Aneurysm
Intervention: Device: TriVascular Stent-Graft System

  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
No text entered.

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
TriVascular Stent Graft This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.

Participant Flow:   Overall Study
    TriVascular Stent Graft  
STARTED     43  
COMPLETED     27  
NOT COMPLETED     16  



  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.
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Reporting Groups
  Description
TriVascular Stent Graft This arm is for patients that receive the TriVascular Stent-Graft System. The TriVascular Stent Graft Systems was designed to treat patients with Abdominal Aortic Aneurysms(AAA). The stent-graft was designed to provide an alternate intraluminal blood conduit and isolate the aneurysm from the blood flow.

Baseline Measures
    TriVascular Stent Graft  
Number of Participants  
[units: participants]
  43  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     39  
Age  
[units: years]
Mean ± Standard Deviation
  73.1  ± 7.9  
Gender  
[units: participants]
 
Female     7  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     43  



  Outcome Measures
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1.  Primary:   Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.   [ Time Frame: 1 month ]

2.  Primary:   Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).   [ Time Frame: 1 month ]

3.  Secondary:   Number of Participants Who Achieve Technical Success of the Stent Graft System.   [ Time Frame: Post procedure ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Colleen Holthe, Clinical Project Manager
Organization: Boston Scientific
phone: 651-581-4632
e-mail: Colleen.Holthe@bsci.com


No publications provided


Responsible Party: Colleen Holthe, Boston Scientific
ClinicalTrials.gov Identifier: NCT00646048     History of Changes
Other Study ID Numbers: S2106
Study First Received: March 26, 2008
Results First Received: June 29, 2010
Last Updated: January 26, 2011
Health Authority: United States: Food and Drug Administration