South American Thoracic Stent-Graft Study

• Sponsor: TriVascular, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01082172
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 17.9
• Patients Per Site Per Month: 0.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm	Device: Implant Thoracic Stent Graft	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thoracic Stent Graft Thoracic Stent Graft implanted device	Device: Implant Thoracic Stent Graft; Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Outcome Measures

Primary Outcome Measures

1. Absence of device-related serious adverse events within 30-days of endovascular procedure [30-Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pontificia Universidad Caolica de Chile	Santiago		Chile

Sponsors and Collaborators

• TriVascular, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• TriVascular Website

Publications

None provided.

• Responsible Party: TriVascular, Inc.
• ClinicalTrials.gov Identifier: NCT01082172
• Other Study ID Numbers: 771-0001 TAA Trial
• First Posted: Mar 8, 2010
• Last Update Posted: Mar 8, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by TriVascular, Inc.: thoracic; aortic; aneurysm; TAA
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Mar 8, 2021