Aortic Aneurysm, ThoracicNCT02266342
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
An observational study of Aortic Aneurysm, Thoracic and Descending Thoracic Aortic Dissection, run by W.L.Gore & Associates at 1 site in France.
Trial summary
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases
- What is being tested?
- GORE® TAG® Thoracic Endoprostheses
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Apr 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.
Who may be able to join
- Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
- Patient who had previously consented to the collection and processing of personal medical data.
- Patient older than 18 years at the time of treatment.
Who cannot join
- Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
- Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.
Read the detailed description
Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.
- Conditions
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases, Aorta Thoracic; Traumatic Rupture, Penetrating Ulcer
- Being tested
- GORE® TAG® Thoracic Endoprostheses
- Medical subject headings
- Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta, Aortic Diseases, Penetrating Atherosclerotic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® TAG® Thoracic EndoprosthesesDevice
Also called Conformable GORE® TAG® Thoracic Endoprostheses
Endovascular therapy to treat thoracic disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With All-cause Mortality (Long-term)
Measured: 5 years
Secondary outcomes (7)
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture
Measured: 5 years
Number of Subjects With Neurological Complications
Measured: 5 years
Number of Subjects With Cardiac, Renal, and Pulmonary Complications
Measured: 5 years
Number of Subjects With Device-related Complications
Measured: 5 years
Number of Subjects With Surgical Conversion
Measured: 5 years
Number of Subjects With Secondary Procedures
Measured: 5 years
Number of Subjects With Disease Related Mortality
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 posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2021
- Study completionApr 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nabil Chakfé, Prof, Principal investigator, Hôpitaux Universitaire de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266342
- Sponsor's protocol ID
- FPR12-03
- Status last verified
- Nov 2023
- First submitted
- 10 Oct 2014
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®
- ClinicalTrials.gov ID
- NCT02266342
- Acronym / sponsor ID
- FPR12-03
- Conditions
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases, Aorta Thoracic; Traumatic Rupture, Penetrating Ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.
Detailed description
Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.
Key inclusion criteria (3 listed)
- Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
- Patient who had previously consented to the collection and processing of personal medical data.
- Patient older than 18 years at the time of treatment.
Key exclusion criteria (2 listed)
- Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
- Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).
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 EndoprosthesesAlso: Conformable GORE® TAG® Thoracic EndoprosthesesEndovascular therapy to treat thoracic disease | Device | – |
Primary outcome
Number of Subjects With All-cause Mortality (Long-term)
Time frame: 5 years
7 secondary outcomes
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture
Time frame: 5 years
Number of Subjects With Neurological Complications
Time frame: 5 years
Number of Subjects With Cardiac, Renal, and Pulmonary Complications
Time frame: 5 years
Number of Subjects With Device-related Complications
Time frame: 5 years
Number of Subjects With Surgical Conversion
Time frame: 5 years
Number of Subjects With Secondary Procedures
Time frame: 5 years
Number of Subjects With Disease Related Mortality
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 19 Apr 2024.
- 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.
Nabil Chakfé, Prof principal investigator
Hôpitaux Universitaire de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, Thoracic and Descending Thoracic Aortic Dissection, run by W.L.Gore & Associates at 1 site in France.
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 3 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 19 Apr 2024. 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 France. 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 19 Apr 2024). 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?
Number of Subjects With All-cause Mortality (Long-term) (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 19 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.