AneurysmNCT00874250
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
A study testing GORE CTAG Device in people with Aneurysm, run by W.L.Gore & Associates at 1 site in United States.
Trial summary
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) > Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aneurysm
- What is being tested?
- GORE CTAG Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 6 Jan 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Presence of DTA aneurysm deemed to warrant surgical repair >
- Fusiform (≥50 mm), or >
- Saccular (no diameter criteria)> 2. Subject is > 21 years of age> 3. Proximal and distal landing zone length ≥ 2.0 cm >
- Landing zones must be in native aorta>
- Landing zone may include left subclavian artery, if necessary> 4. All proximal and distal landing zone inner diameters are between 16-42 mm>
- Diameter assessed by flow lumen and thrombus, if present; calcium excluded> 5. Life expectancy > 2 years> 6. Able to tolerate thoracotomy > 7. Male or infertile female> 8. Able to comply with protocol requirements including following-up> 9. Signed informed consent>
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)>
- Mycotic aneurysm>
- Hemodynamically unstable aneurysm rupture>
- Aortic dissection>
Show all 15Show fewer
- Planned coverage of left carotid or celiac arteries with the CTAG Device>
- Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date>
- Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome>
- Known history of drug abuse>
- ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)>
- NYHA class IV >
- Participating in another investigational device or drug study within 1 year of treatment>
- Subject has known sensitivities or allergies to the device materials>
- Subject has a systemic infection and may be at increased risk of endovascular graft infection>
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Medical Center
Birmingham, Alabama, 35294
About this study
Official title: An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA)
> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
- Conditions
- Aneurysm
- Being tested
- GORE CTAG Device
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE CTAG DeviceDevice
Also called GORE Conformable TAG® Thoracic Endoprosthesis
Endovascular aortic stent-graft
| Study group | Role | What they receive |
|---|---|---|
| GORE CTAG Device | Experimental | The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis. Receives: Device: GORE CTAG Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
Measured: Treatment through 1 month post treatment
Secondary outcomes (8)
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Measured: Treatment through 1 month post procedure
Procedure Time (Minutes)
Total time in minutes required for surgical device implantation.
Measured: Initial Device Implant Procedure During Index Hospitalization
Operative Blood Loss (mL)
Blood loss in mL during initial device implantation procedure
Measured: Initial Device Implant Procedure During Index Hospitalization
Days of Convalescence Stay in an Intensive Care Unit
Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Measured: During the Index Hospitalization
Total Length of Hospital Stay (Days)
Total days of hospital stay during the initial hospitalization for implantation of device
Measured: Total Duration of the Index Hospitalization
Time in Days to Return to Normal Daily Activities
This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Measured: Average time within one month window
Procedural Survival
Subjects who survived the index procedure
Measured: Initial Device Implant Procedure During Index Hospitalization
Intensive Care Unit (ICU) Stay
Subjects admitted to ICU during index hospitalization
Measured: Initial Device Implant Index Hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2011
- Study completion6 Jan 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 (2)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies 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
- William D Jordan, Dr., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874250
- Sponsor's protocol ID
- TAG 08-03
- Status last verified
- Jul 2017
- First submitted
- 31 Mar 2009
- Last updated
- 25 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial. J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20.
PubMed 34022380Panthofer 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
- An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
- ClinicalTrials.gov ID
- NCT00874250
- Acronym / sponsor ID
- TAG 08-03
- Conditions
- Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 13 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA)
> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE CTAG Device | Experimental | Device: GORE CTAG DeviceThe primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable 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 (6 listed)
- 1. Presence of DTA aneurysm deemed to warrant surgical repair >
- Fusiform (≥50 mm), or >
- Saccular (no diameter criteria)> 2. Subject is > 21 years of age> 3. Proximal and distal landing zone length ≥ 2.0 cm >
- Landing zones must be in native aorta>
- Landing zone may include left subclavian artery, if necessary> 4. All proximal and distal landing zone inner diameters are between 16-42 mm>
Key exclusion criteria (15 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)>
- Mycotic aneurysm>
- Hemodynamically unstable aneurysm rupture>
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 CTAG DeviceAlso: GORE Conformable TAG® Thoracic EndoprosthesisEndovascular aortic stent-graft | Device | GORE CTAG Device |
Primary outcome
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
Time frame: Treatment through 1 month post treatment
8 secondary outcomes
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Time frame: Treatment through 1 month post procedure
Procedure Time (Minutes)
Time frame: Initial Device Implant Procedure During Index Hospitalization
Operative Blood Loss (mL)
Time frame: Initial Device Implant Procedure During Index Hospitalization
Days of Convalescence Stay in an Intensive Care Unit
Time frame: During the Index Hospitalization
Total Length of Hospital Stay (Days)
Time frame: Total Duration of the Index Hospitalization
Time in Days to Return to Normal Daily Activities
Time frame: Average time within one month window
Procedural Survival
Time frame: Initial Device Implant Procedure During Index Hospitalization
Intensive Care Unit (ICU) Stay
Time frame: Initial Device Implant Index Hospitalization
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 34022380Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial. J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20.
- 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.
- Individual participant dataSharing planned: No
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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.
William D Jordan, Dr. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE CTAG Device in people with Aneurysm, 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 6 inclusion and 15 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2011). 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?
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment (time frame: Treatment through 1 month post treatment). 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 NCT00874250, 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 25 Aug 2017.