Aortic Aneurysm, ThoracicPhase 2NCT00608829
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
A Phase 2 study testing GORE TAG® Thoracic Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 1 site in United States.
Trial summary
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta. 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
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Sep 2014
- Phase
- Phase 2
- 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
- Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair
- Fusiform (≥50 mm), or
- Saccular (no diameter criteria)
- All proximal and/or all distal landing zone inner diameters between 37-42 mm
- Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications
- Proximal and distal landing zone length greater than 2.0 cm
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- Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
- Life expectancy > 2 years
- Subject is open surgical candidate defined as:
- Able to tolerate thoracotomy
- American Society of Anesthesiologists class I-IV (class V excluded)
- New York Heart Association class I-III or not applicable (class IV excluded)
- Male or infertile female
- Age greater than 21 years
- Able to comply with study protocol requirements, including follow-up
Who cannot join
- Mycotic aneurysm
- Hemodynamically unstable aneurysm rupture
- Aortic dissection
- Planned occlusion of left carotid or celiac arteries
- Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
- Myocardial infarction or stroke within 6 weeks of treatment
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- Pre-treatment creatinine > 2.0 mg/dL
- Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- Participation in another drug or device study within 1 year of treatment
- History of drug abuse within 6 months of treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
- 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
Also called GORE TAG® Thoracic Endoprosthesis - 45 mm
Implant
| Study group | Role | What they receive |
|---|---|---|
| GORE TAG® Thoracic Endoprosthesis | Experimental | Gore 45mm TAG Thoracic Endograft Implantation Receives: Device: GORE TAG® Thoracic Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startFeb 2007
- Primary completionAug 2009
- Study completionSep 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Makaroun, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608829
- Sponsor's protocol ID
- TAG 06-02
- Status last verified
- Mar 2015
- First submitted
- 20 Dec 2007
- Last updated
- 5 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
- ClinicalTrials.gov ID
- NCT00608829
- Acronym / sponsor ID
- TAG 06-02
- Conditions
- Aortic Aneurysm, Thoracic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 15 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms 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 TAG® Thoracic Endoprosthesis | Experimental | Device: GORE TAG® Thoracic EndoprosthesisGore 45mm TAG Thoracic Endograft Implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair
- All proximal and/or all distal landing zone inner diameters between 37-42 mm
- Proximal and distal landing zone length greater than 2.0 cm
- Life expectancy > 2 years
- Subject is open surgical candidate defined as:
Key exclusion criteria (10 listed)
- Mycotic aneurysm
- Hemodynamically unstable aneurysm rupture
- Aortic dissection
- Planned occlusion of left carotid or celiac arteries
- Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
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 EndoprosthesisAlso: GORE TAG® Thoracic Endoprosthesis - 45 mmImplant | Device | GORE TAG® Thoracic Endoprosthesis |
Primary outcome
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
Time frame: one year
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- 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.
Michel Makaroun, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GORE TAG® Thoracic Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 1 site 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 15 inclusion and 10 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 5 Mar 2015. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2010). 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?
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment (time frame: one year). 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 5 Mar 2015.