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NCT01082172 Clinical Trial

South American Thoracic Stent-Graft Study

Thoracic Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01082172
Other study ID # 771-0001 TAA Trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date May 2011

Study information
Verified date March 2021
Source Endologix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date May 2011
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Chile Pontificia Universidad Caolica de Chile Santiago

Sponsors (1)
Lead Sponsor Collaborator
TriVascular, Inc.

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of device-related serious adverse events within 30-days of endovascular procedure 30-Days
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