Thoracic InjuriesNCT00917852
Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
A study testing Gore Conformable TAG Thoracic Endoprosthesis in people with Thoracic Injuries, run by W.L.Gore & Associates at 26 sites in United States.
Trial summary
TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Injuries
- What is being tested?
- Gore Conformable TAG Thoracic Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 26 sitesUnited States
- Study dates
- Nov 2009to 28 Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic transection of the DTA that requires repair, determined by the treating physician
- Traumatic aortic transection location between, but does not include, the left subclavian artery and celiac artery
- Endovascular repair with the GORE Conformable TAG® Device performed less than or = to 14 days after aortic injury
- Age greater than or equal to 18 years
- Proximal and distal landing zone length greater than or equal to 2.0 cm. Landing zones must be in native aorta. Landing zone may include left subclavian artery, if necessary
- All proximal and distal landing zone inner diameters are between 16-42 mm. Diameter assessed by flow lumen and thrombus, if present; calcium excluded
- Subject capable of complying with study protocol requirements, including follow-up
- Informed Consent Form signed by subject or legal representative
Who cannot join
- Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper
- Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
- Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
- Infected aorta
- Subject has a systemic infection and may be at increased risk of endovascular graft infection
- Planned coverage of left carotid or celiac arteries with the CTAG Device
Show all 13Show fewer
- Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- Treatment in another drug or medical device study within 1 year of study enrollment
- Known history of drug abuse
- Pregnant female
- Moribund patient not expected to live 24 hours with or without operation, determined by the treating physician
- Injury Severity Score of 75
- Subject has known sensitivities or allergies to the device materials
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Ann Arbor, Michigan
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Chapel Hill, North Carolina, 27599
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Greenville, North Carolina
Study site
Greenville, South Carolina
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Knoxville, Tennessee
Study site
Lake Success, New York
Study site
Lebanon, New Hampshire
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
Omaha, Nebraska
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Stanford, California
Study site
Tampa, Florida
Study site
Temple, Texas
About this study
Official title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta
TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta.
- Conditions
- Thoracic Injuries
- Being tested
- Gore Conformable TAG Thoracic Endoprosthesis
- Keywords
- aorta, trauma, transection
- Medical subject headings
- Thoracic Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gore Conformable TAG Thoracic EndoprosthesisDevice
Endovascular stent graft
| Study group | Role | What they receive |
|---|---|---|
| GORE Conformable TAG® Thoracic Endoprosthesis | Experimental | Not described Receives: Device: Gore Conformable TAG Thoracic Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Measured: 30 days post-treatment
Major Device Events
Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.
Measured: 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completion28 Feb 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic InjuriesStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Farber, M.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917852
- Sponsor's protocol ID
- TAG 08-02
- Status last verified
- Jul 2017
- First submitted
- 8 Jun 2009
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28.
PubMed 30598352
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta
- ClinicalTrials.gov ID
- NCT00917852
- Acronym / sponsor ID
- TAG 08-02
- Conditions
- Thoracic Injuries
- Keywords
- aorta, trauma, transection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Posted 1 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE Conformable TAG® Thoracic Endoprosthesis | Experimental | Device: Gore Conformable TAG Thoracic Endoprosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Traumatic transection of the DTA that requires repair, determined by the treating physician
- Traumatic aortic transection location between, but does not include, the left subclavian artery and celiac artery
- Endovascular repair with the GORE Conformable TAG® Device performed less than or = to 14 days after aortic injury
- Age greater than or equal to 18 years
- Proximal and distal landing zone length greater than or equal to 2.0 cm. Landing zones must be in native aorta. Landing zone may include left subclavian artery, if necessary
Key exclusion criteria (13 listed)
- Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper
- Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
- Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
- Infected aorta
- Subject has a systemic infection and may be at increased risk of endovascular graft infection
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 |
|---|---|---|
| Gore Conformable TAG Thoracic EndoprosthesisEndovascular stent graft | Device | GORE Conformable TAG® Thoracic Endoprosthesis |
Primary outcome
All Cause Mortality
Time frame: 30 days post-treatment
Major Device Events
Time frame: 1 month post-treatment
Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30598352Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28.
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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.
Mark Farber, M.D. principal investigator
University of North Carolina, Chapel Hill
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gore Conformable TAG Thoracic Endoprosthesis in people with Thoracic Injuries, run by W.L.Gore & Associates at 26 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 8 inclusion and 13 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 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 1 May 2012). 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 post-treatment). The study lists 2 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 NCT00917852, which also lists 1 linked publication.
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 25 Aug 2017.