South American Thoracic Stent-Graft Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Thoracic Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thoracic Stent Graft

Thoracic Stent Graft implanted device

Group Type EXPERIMENTAL

Implant Thoracic Stent Graft

Intervention Type DEVICE

Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Interventions

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Implant Thoracic Stent Graft

Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No