South American Thoracic Stent-Graft Study

Not Applicable

Completed

• Conditions: Thoracic Aortic Aneurysm
• Interventions: Device: Implant Thoracic Stent Graft

• Registration Number: NCT01082172
• Lead Sponsor: TriVascular, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Primary Completion: 2010-05
• Study Completion: 2011-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic Stent Graft	Implant Thoracic Stent Graft	Thoracic Stent Graft implanted device

Primary Outcome Measures

Name	Time	Method
Absence of device-related serious adverse events within 30-days of endovascular procedure	30-Days

Trial Locations

Locations (1)

Pontificia Universidad Caolica de Chile; 🇨🇱 Santiago, Chile