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South 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
TriVascular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysm focused on measuring thoracic, aortic, aneurysm, TAA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 4, 2010
Last Updated
March 4, 2021
Sponsor
TriVascular, Inc.
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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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