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South American Thoracic Stent-Graft Study

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ClinicalTrials.gov Identifier: NCT01082172
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : November 9, 2012
Sponsor:
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

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

U.S. FDA Resources


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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01082172


Locations
Chile
Pontificia Universidad Caolica de Chile
Santiago, Chile
Sponsors and Collaborators
TriVascular, Inc.

Additional Information:
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01082172     History of Changes
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.:
thoracic
aortic
aneurysm
TAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases