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South American Thoracic Stent-Graft Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082172
First Posted: March 8, 2010
Last Update Posted: November 9, 2012
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.
Information provided by (Responsible Party):
TriVascular, Inc.
  Purpose
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 Intervention Phase
Thoracic Aortic Aneurysm Device: Implant Thoracic Stent Graft Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by TriVascular, Inc.:

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

Enrollment: 2
Study Start Date: November 2009
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implant Thoracic Stent Graft
    Endovascular implant of Thoracic Aortic Aneurysm Stent Graft
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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.
  More Information

Additional Information:
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01082172     History of Changes
Other Study ID Numbers: 771-0001 TAA Trial
First Submitted: March 4, 2010
First Posted: March 8, 2010
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