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

March 4, 2010
November 8, 2012
November 2009
May 2010   (final data collection date for primary outcome measure)
Absence of device-related serious adverse events within 30-days of endovascular procedure [ Time Frame: 30-Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01082172 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
South American Thoracic Stent-Graft Study
A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic Aortic Aneurysm
Device: Implant Thoracic Stent Graft
Endovascular implant of Thoracic Aortic Aneurysm Stent Graft
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
May 2011
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT01082172
771-0001 TAA Trial
No
TriVascular, Inc.
TriVascular, Inc.
Not Provided
Not Provided
TriVascular, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP