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South American Thoracic Stent-Graft Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082172
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : November 9, 2012
Information provided by (Responsible Party):
TriVascular, Inc.

Brief Summary:
A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysm Device: Implant Thoracic Stent Graft Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Implant Thoracic Stent Graft
    Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Primary Outcome Measures :
  1. Absence of device-related serious adverse events within 30-days of endovascular procedure [ Time Frame: 30-Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:

    • Adequate iliac/femoral access compatible with the required delivery systems,
    • Non-aneurysmal aortic segments proximal and distal to the aneurysm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01082172

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Pontificia Universidad Caolica de Chile
Santiago, Chile
Sponsors and Collaborators
TriVascular, Inc.
Additional Information:
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Responsible Party: TriVascular, Inc. Identifier: NCT01082172    
Other Study ID Numbers: 771-0001 TAA Trial
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012
Keywords provided by TriVascular, Inc.:
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases