Thoracic AortaTRANSFIXNCT01688050

TRANSFIX Zenith® Transection Clinical Study

A study testing Zenith® TX2® Low Profile Endovascular Graft in people with Thoracic Aorta and Thoracic Injuries, run by Cook Research Incorporated at 21 sites in United States.

Completed

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

Official record

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Trial summary

The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Thoracic Aorta, Thoracic Injuries, Blunt Injuries
What is being tested?: Zenith® TX2® Low Profile Endovascular Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 21 sitesUnited States
Study dates: 23 Jan 2013to 29 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Vessels suitable for endovascular access and stent graft placement
Blunt thoracic aortic injury of the descending thoracic aorta
At least 16 years of age
Informed consent given by patient or legally authorized representative

Who cannot join

Clinical considerations that would compromise patient safety or study outcomes
Unsuitable arterial anatomy

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Maryland Medical Center
Baltimore, Maryland, 21201
Cooper University Hospital
Camden, New Jersey, 08103
University of North Carolina Vascular Surgery
Chapel Hill, North Carolina, 27599
University of Virginia Medical Center
Charlottesville, Virginia, 22908
University of Cincinnati University Hospital
Cincinnati, Ohio, 45267
UT Southwestern Medical Center - Parkland Memorial Hospital
Dallas, Texas, 75235
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Tennessee Medical School
Knoxville, Tennessee, 37920
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Keck Hospital of USC
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40292
University of Miami School of Medicine
Miami, Florida, 33136
Rutgers University
Newark, New Jersey, 07103
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
Mercy Hospital St. Louis
St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury

The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.

Conditions: Thoracic Aorta, Thoracic Injuries, Blunt Injuries
Being tested: Zenith® TX2® Low Profile Endovascular Graft
Keywords: Blunt thoracic aortic injury, Transection, Endovascular graft
Medical subject headings: Thoracic Injuries, Wounds, Nonpenetrating

What participants receive

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

Zenith® TX2® Low Profile Endovascular GraftDevice
Also called Zenith Alpha Thoracic™ Endovascular Graft
Treatment of Blunt thoracic aortic injuries (BTAIs)

Study groups in NCT01688050
Study group	Role	What they receive
Endovascular Repair	Experimental	Not described Receives: Device: Zenith® TX2® Low Profile Endovascular Graft

What is being measured

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

All-cause Mortality
Measured: 30 days
Aortic Injury-related Mortality
Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.
Measured: 30 days
Device Success
Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.
Measured: 30 days

Timeline

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

23 Jan 201329 Jul 2019

First posted19 Sep 2012 (estimated)
Study start23 Jan 2013
Primary completionJun 2014
Study completion29 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Thoracic AortaStudies 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01688050
Sponsor's protocol ID: 11-004
Acronym: TRANSFIX
Status last verified: Oct 2020
First submitted: 14 Sep 2012
Last updated: 18 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Starnes BW, Dwivedi A, Giglia J, Woo K, Yeh C; TRANSFIX Study Investigators. Updated outcomes from the TRANSFIX study to evaluate endovascular repair of blunt thoracic aortic injuries with the Zenith Alpha thoracic device. J Vasc Surg. 2020 Jun;71(6):1851-1857. doi: 10.1016/j.jvs.2019.05.070. Epub 2020 Feb 1.
PubMed 32014287
Starnes BW, Dwivedi AJ, Giglia JS, Woo K, Yeh C; TRANSFIX Study Investigators. Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. J Vasc Surg. 2015 Dec;62(6):1495-503.e1. doi: 10.1016/j.jvs.2015.07.098. Epub 2015 Sep 26.
PubMed 26391458

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

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All Thoracic Aorta trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TRANSFIX - Zenith® TX2® Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury
ClinicalTrials.gov ID: NCT01688050
Acronym / sponsor ID: TRANSFIX / 11-004
Conditions: Thoracic Aorta, Thoracic Injuries, Blunt Injuries
Keywords: Blunt thoracic aortic injury, Transection, Endovascular graft
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Cook Research IncorporatedIndustry (pharma, biotech, devices)
Study start: 23 Jan 2013 (actual)
Primary completion: Jun 2014 (actual)
Study completion: 29 Jul 2019 (actual)
First posted: 19 Sep 2012 (estimated)
Results: Posted 18 Nov 2015

Clinical summary

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

The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.

Study design

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

Arm	Type	Receives
Endovascular Repair	Experimental	Device: Zenith® TX2® Low Profile Endovascular Graft

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Vessels suitable for endovascular access and stent graft placement
Blunt thoracic aortic injury of the descending thoracic aorta
At least 16 years of age
Informed consent given by patient or legally authorized representative

Key exclusion criteria (2 listed)

Clinical considerations that would compromise patient safety or study outcomes
Unsuitable arterial anatomy

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
Zenith® TX2® Low Profile Endovascular GraftAlso: Zenith Alpha Thoracic™ Endovascular GraftTreatment of Blunt thoracic aortic injuries (BTAIs)	Device	Endovascular Repair

Primary outcome

All-cause Mortality
Time frame: 30 days
Aortic Injury-related Mortality
Time frame: 30 days
Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.
Device Success
Time frame: 30 days
Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.

Results and safety

Results posted to the registry on 18 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endovascular Repair	50	19

Primary outcome: All-cause Mortality

Time frame: 30 days. Number. Unit: participants

Measure	Endovascular Repair n = 50
Value	1

Endovascular Repair: All-cause mortality rate (%): 2.0 (95% CI 0 to 5.88)

Population analysed: One death was adjudicated as unrelated by the Clinical Events Committee (CEC).

Primary outcome: Aortic Injury-related Mortality

Time frame: 30 days. Number. Unit: participants

Measure	Endovascular Repair n = 50
Value	0

Endovascular Repair: Aortic injury-related mortality rate (%): 0 (95% CI 0 to 7.1)

Primary outcome: Device Success

Time frame: 30 days. Number. Unit: participants

Measure	Endovascular Repair n = 50
Value	48

Endovascular Repair: Device success rate (%): 96.0 (95% CI 90.6 to 100)

Population analysed: One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.

Adverse events

Time frame: 5-Year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endovascular Repair	30 of 50 (60%)	21 of 50 (42%)	7 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32014287Starnes BW, Dwivedi A, Giglia J, Woo K, Yeh C; TRANSFIX Study Investigators. Updated outcomes from the TRANSFIX study to evaluate endovascular repair of blunt thoracic aortic injuries with the Zenith Alpha thoracic device. J Vasc Surg. 2020 Jun;71(6):1851-1857. doi: 10.1016/j.jvs.2019.05.070. Epub 2020 Feb 1.
Derived from this study: PubMed 26391458Starnes BW, Dwivedi AJ, Giglia JS, Woo K, Yeh C; TRANSFIX Study Investigators. Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. J Vasc Surg. 2015 Dec;62(6):1495-503.e1. doi: 10.1016/j.jvs.2015.07.098. Epub 2015 Sep 26.

Related trials for Thoracic Aorta

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Recruiting
Speed-up the Diagnosis and Evaluation of anoMalous Coronary ARTery From the Aorta
AAOCA, ACAOS

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.

Benjamin Starnes, MD principal investigator

University of Washington - Harborview, Division of Vascular Surgery

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

Questions about this trial

What is this clinical trial studying?

A study testing Zenith® TX2® Low Profile Endovascular Graft in people with Thoracic Aorta and Thoracic Injuries, run by Cook Research Incorporated at 21 sites in United States.

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 4 inclusion and 2 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. 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?

Yes. Results are posted in the registry (first posted 18 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

All-cause Mortality (time frame: 30 days). The study lists 3 primary outcomes in all. 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 NCT01688050, which also lists 2 linked publications.

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 18 Nov 2020.