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OpenTrials
Completed

NCT Number: NCT01082172

South American Thoracic Stent-Graft Study

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).

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Caolica de Chile

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant Thoracic Stent Graft

Device

Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Primary outcomes

  1. Absence of device-related serious adverse events within 30-days of endovascular procedure

    Time frame: 30-Days

Sponsors and collaborators

Lead sponsor

TriVascular, Inc.

Industry

Registry information

Official study title

A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 8, 2010
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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