- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01082172
South American Thoracic Stent-Graft Study
March 4, 2021 updated by: TriVascular, Inc.
A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Santiago, Chile
- Pontificia Universidad Caolica de Chile
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thoracic Stent Graft
Thoracic Stent Graft implanted device
|
Endovascular implant of Thoracic Aortic Aneurysm Stent Graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absence of device-related serious adverse events within 30-days of endovascular procedure
Time Frame: 30-Days
|
30-Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
March 4, 2010
First Submitted That Met QC Criteria
March 5, 2010
First Posted (Estimate)
March 8, 2010
Study Record Updates
Last Update Posted (Actual)
March 8, 2021
Last Update Submitted That Met QC Criteria
March 4, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 771-0001 TAA Trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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