Back to resultsSouth American Thoracic Stent-Graft Study
Primary Purpose
Thoracic Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Implant Thoracic Stent Graft
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Aortic Aneurysm focused on measuring thoracic, aortic, aneurysm, TAA
Eligibility 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.
Sites / Locations
- Pontificia Universidad Caolica de Chile
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thoracic Stent Graft
Arm Description
Thoracic Stent Graft implanted device
Outcomes
Primary Outcome Measures
Absence of device-related serious adverse events within 30-days of endovascular procedure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01082172
Brief Title
South American Thoracic Stent-Graft Study
Official Title
A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriVascular, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Aneurysm
Keywords
thoracic, aortic, aneurysm, TAA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracic Stent Graft
Arm Type
Experimental
Arm Description
Thoracic Stent Graft implanted device
Intervention Type
Device
Intervention Name(s)
Implant Thoracic Stent Graft
Intervention Description
Endovascular implant of Thoracic Aortic Aneurysm Stent Graft
Primary Outcome Measure Information:
Title
Absence of device-related serious adverse events within 30-days of endovascular procedure
Time Frame
30-Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pontificia Universidad Caolica de Chile
City
Santiago
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
South American Thoracic Stent-Graft Study
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