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CompletedNCT02266342Updated Apr 19, 2024Results posted

GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry

An observational study in Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection and Aortic Diseases, sponsored by W.L.Gore & Associates. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by W.L.Gore & Associates · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Aortic Aneurysm, Thoracic
  • Descending Thoracic Aortic Dissection
  • Aortic Diseases
  • Aorta Thoracic; Traumatic Rupture
  • Penetrating Ulcer
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In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's enrollment of 154 is close to the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.

Browse W.L.Gore & Associates studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • DeviceGORE® TAG® Thoracic Endoprostheses

    Endovascular therapy to treat thoracic disease

    Also known as: Conformable GORE® TAG® Thoracic Endoprostheses

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What researchers measure

Primary outcomes

  1. Number of Subjects With All-cause Mortality (Long-term)

    Time frame: 5 years

Secondary outcomes

  1. Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture

    Time frame: 5 years

  2. Number of Subjects With Neurological Complications

    Time frame: 5 years

  3. Number of Subjects With Cardiac, Renal, and Pulmonary Complications

    Time frame: 5 years

  4. Number of Subjects With Device-related Complications

    Time frame: 5 years

  5. Number of Subjects With Surgical Conversion

    Time frame: 5 years

  6. Number of Subjects With Secondary Procedures

    Time frame: 5 years

  7. Number of Subjects With Disease Related Mortality

    Time frame: 5 years

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Results

Posted Apr 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneGORE® TAG® Thoracic Endoprothesis
Started154
Completed60
Not completed94

Outcome measures

PrimaryNumber of Subjects With All-cause Mortality (Long-term)
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With All-cause Mortality (Long-term)
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With All-cause Mortality (Long-term)31
SecondaryNumber of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture50
SecondaryNumber of Subjects With Neurological Complications
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Neurological Complications
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Neurological Complications13
SecondaryNumber of Subjects With Cardiac, Renal, and Pulmonary Complications
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Cardiac, Renal, and Pulmonary Complications
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Cardiac, Renal, and Pulmonary Complications32
SecondaryNumber of Subjects With Device-related Complications
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Device-related Complications
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Device-related Complications8
SecondaryNumber of Subjects With Surgical Conversion
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Surgical Conversion
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Surgical Conversion0
SecondaryNumber of Subjects With Secondary Procedures
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Secondary Procedures
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Secondary Procedures27
SecondaryNumber of Subjects With Disease Related Mortality
Time frame:
5 years
Reported as:
Count of participants · Participants
Number of Subjects With Disease Related Mortality
ParticipantsGORE® TAG® Thoracic Endoprothesis
Number of Subjects With Disease Related Mortality5

Adverse events

Collected over Five year follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GORE® TAG® Thoracic Endoprothesis31/154 (20.1%)79/154 (51.3%)38/154 (24.7%)
Most frequent serious events
Most frequent serious events
EventGORE® TAG® Thoracic Endoprothesis
VascularVascular disorders40/154
OtherGeneral disorders24/154
CardiacCardiac disorders13/154
NeurologicalNervous system disorders12/154
PulmonaryRespiratory, thoracic and mediastinal disorders12/154
RenalRenal and urinary disorders6/154
Most frequent other events
Most frequent other events
EventGORE® TAG® Thoracic Endoprothesis
VascularVascular disorders24/154
CardiacCardiac disorders5/154
OtherGeneral disorders5/154
PulmonaryRespiratory, thoracic and mediastinal disorders4/154
NeurologicalNervous system disorders2/154
RenalRenal and urinary disorders2/154

Baseline characteristics

Age, Continuous
Age, Continuous(years)GORE® TAG® Thoracic Endoprothesis
Median68 (59 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)GORE® TAG® Thoracic Endoprothesis
Female49
Male105
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)GORE® TAG® Thoracic Endoprothesis
Region of Enrollment
Region of Enrollment(participants)GORE® TAG® Thoracic Endoprothesis
France154
Main Indication for Implantation
Main Indication for Implantation(Participants)GORE® TAG® Thoracic Endoprothesis
Thoracic Aortic Aneurysm56
Type B Dissection of the Thoracic Aorta60
Traumatic Wound15
Penetrating Aortic Ulcer17
Other6
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Study locations

1 site
  • Hopitaux Universitaire de Strasbourg
    Strasbourg, 67091, France
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02266342
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Oct 17, 2014
Start date
Oct 2014
Primary completion
Dec 2021
Completion
Apr 2022
Results posted
Apr 19, 2024
Last update
Apr 19, 2024

Study contacts

Nabil Chakfé, Prof
principal investigator · Hôpitaux Universitaire de Strasbourg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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