Thoracic Aortic AneurysmNCT01082172

South American Thoracic Stent-Graft Study

A study testing Implant Thoracic Stent Graft in people with Thoracic Aortic Aneurysm, run by TriVascular, Inc. at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thoracic Aortic Aneurysm
What is being tested?: Implant Thoracic Stent Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteChile
Study dates: Nov 2009to May 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Chile1 site

Pontificia Universidad Caolica de Chile
Santiago

Other trials in Chile

About this study

Official title: A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System

Conditions: Thoracic Aortic Aneurysm
Being tested: Implant Thoracic Stent Graft
Keywords: thoracic, aortic, aneurysm, TAA
Medical subject headings: Aortic Aneurysm, Thoracic, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implant Thoracic Stent GraftDevice
Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Study groups in NCT01082172
Study group	Role	What they receive
Thoracic Stent Graft	Experimental	Thoracic Stent Graft implanted device Receives: Device: Implant Thoracic Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

Absence of device-related serious adverse events within 30-days of endovascular procedure
Measured: 30-Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009May 2011

First posted8 Mar 2010 (estimated)
Study startNov 2009
Primary completionMay 2010
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01082172
Sponsor's protocol ID: 771-0001 TAA Trial
Status last verified: Mar 2021
First submitted: 4 Mar 2010
Last updated: 8 Mar 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm

All Thoracic Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
ClinicalTrials.gov ID: NCT01082172
Acronym / sponsor ID: 771-0001 TAA Trial
Conditions: Thoracic Aortic Aneurysm
Keywords: thoracic, aortic, aneurysm, TAA
Study type: Interventional
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: TriVascular, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: May 2010 (actual)
Study completion: May 2011 (actual)
First posted: 8 Mar 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Thoracic Stent Graft	Experimental	Device: Implant Thoracic Stent GraftThoracic Stent Graft implanted device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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:

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implant Thoracic Stent GraftEndovascular implant of Thoracic Aortic Aneurysm Stent Graft	Device	Thoracic Stent Graft

Primary outcome

Absence of device-related serious adverse events within 30-days of endovascular procedure
Time frame: 30-Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.

Related trials for Thoracic Aortic Aneurysm

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implant Thoracic Stent Graft in people with Thoracic Aortic Aneurysm, run by TriVascular, Inc. at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of device-related serious adverse events within 30-days of endovascular procedure (time frame: 30-Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01082172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.