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South American Thoracic Stent-Graft Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01082172
First received: March 4, 2010
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082172

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

Additional Information:
TriVascular Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01082172     History of Changes
Other Study ID Numbers: 771-0001 TAA Trial
Study First Received: March 4, 2010
Last Updated: November 8, 2012
Health Authority: Chile: Instituto de Salud Publica de Chile

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

ClinicalTrials.gov processed this record on June 18, 2013