Aortic Aneurysm, ThoracicNCT00590759
Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
A study testing GORE TAG® Thoracic Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 25 sites in United States.
Trial summary
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- GORE TAG® Thoracic Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 25 sitesUnited States
- Study dates
- Aug 2005to Apr 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Descending thoracic aortic aneurysm deemed to warrant surgical repair:
- Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta
- Saccular aneurysm
- Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
- <60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment
Show all 14Show fewer
- Life expectancy > 2 years
- Surgical Candidate
- ASA Class I, II, III, or IV
- NYHA Class I, II, III or no heart disease
- Male or infertile female
- Minimum 21 years of age
- Able to comply with protocol requirements
- Signed Informed Consent Form
Who cannot join
- 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
- Significant thrombus at the proximal or distal implantation zones
- Mycotic aneurysm
- Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
- Acute or chronic aortic dissection
- Planned occlusion of the left carotid or celiac arteries
Show all 13Show fewer
- "Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days
- Myocardial infarction or cerebral vascular accident within 6 weeks
- Severe respiratory insufficiency sufficient that precludes open thoracotomy
- Renal insufficiency (Creatinine > 2.0 mg/dL) with or without dialysis
- Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
- Participation in another investigational device or drug study within 1 year
- Documented history of drug abuse within 6 months
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Study site
Albany, New York
Study site
Boston, Massachusetts
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Gainesville, Florida
Study site
Greeley, Colorado
Study site
Kansas City, Kansas
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Peoria, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
St Louis, Missouri
Study site
Temple, Texas
Study site
Vancouver, Washington
About this study
Official title: A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- GORE TAG® Thoracic Endoprosthesis
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE TAG® Thoracic EndoprosthesisDevice
implant
| Study group | Role | What they receive |
|---|---|---|
| GORE TAG® Thoracic Endoprosthesis | Other | Not described Receives: Device: GORE TAG® Thoracic Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm Related Death
Freedom from aneurysm related mortality for TAG 05-02 subjects
Measured: 5 years
Secondary outcomes (1)
A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
Proportion of subjects in TAG 05-02 with MAEs
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startAug 2005
- Primary completionApr 2013
- Study completionApr 2013
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.
- Other trials for Aortic Aneurysm, ThoracicStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Morasch, M.D., Principal investigator, St. Vincent's Healthcare, Billings MT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590759
- Sponsor's protocol ID
- TAG 05-02
- Status last verified
- Aug 2014
- First submitted
- 20 Dec 2007
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT00590759
- Acronym / sponsor ID
- TAG 05-02
- Conditions
- Aortic Aneurysm, Thoracic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE TAG® Thoracic Endoprosthesis | Other | Device: GORE TAG® Thoracic Endoprosthesis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Descending thoracic aortic aneurysm deemed to warrant surgical repair:
- Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
- Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
- Life expectancy > 2 years
- Surgical Candidate
Key exclusion criteria (13 listed)
- 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta
- Significant thrombus at the proximal or distal implantation zones
- Mycotic aneurysm
- Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)
- Acute or chronic aortic dissection
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 TAG® Thoracic Endoprosthesisimplant | Device | GORE TAG® Thoracic Endoprosthesis |
Primary outcome
Aneurysm Related Death
Time frame: 5 years
Freedom from aneurysm related mortality for TAG 05-02 subjects
1 secondary outcome
A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Morasch, M.D. principal investigator
St. Vincent's Healthcare, Billings MT
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE TAG® Thoracic Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 25 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 14 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 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 7 Aug 2014). 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?
Aneurysm Related Death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2014.