Aorta Thoracic; Traumatic Rupture, Aortic Aneurysm, Thoracic, Aortic Diseases, Descending Thoracic Aortic Dissection, Penetrating Ulcer
Conditions
Brief 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.
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.
Interventions
DEVICEGORE® TAG® Thoracic Endoprostheses
Endovascular therapy to treat thoracic disease
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Subjects With All-cause Mortality (Long-term) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With Neurological Complications | 5 years |
| Number of Subjects With Cardiac, Renal, and Pulmonary Complications | 5 years |
| Number of Subjects With Device-related Complications | 5 years |
| Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture | 5 years |
| Number of Subjects With Secondary Procedures | 5 years |
| Number of Subjects With Disease Related Mortality | 5 years |
| Number of Subjects With Surgical Conversion | 5 years |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® TAG® Thoracic Endoprothesis Patients receiving a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis implant for the treatment of a descending thoracic aortic disease. | 154 |
| Total | 154 |
Baseline characteristics
| Characteristic | GORE® TAG® Thoracic Endoprothesis | — |
|---|---|---|
| Age, Continuous | 68 years | — |
| Main Indication for Implantation Other | 6 Participants | — |
| Main Indication for Implantation Penetrating Aortic Ulcer | 17 Participants | — |
| Main Indication for Implantation Thoracic Aortic Aneurysm | 56 Participants | — |
| Main Indication for Implantation Traumatic Wound | 15 Participants | — |
| Main Indication for Implantation Type B Dissection of the Thoracic Aorta | 60 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 154 participants | — |
| Sex: Female, Male Female | 49 Participants | — |
| Sex: Female, Male Male | 105 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 31 / 154 |
| other Total, other adverse events | 38 / 154 |
| serious Total, serious adverse events | 79 / 154 |
Outcome results
Primary
Number of Subjects With All-cause Mortality (Long-term)
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With All-cause Mortality (Long-term) | 31 Participants |
Secondary
Number of Subjects With Cardiac, Renal, and Pulmonary Complications
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Cardiac, Renal, and Pulmonary Complications | 32 Participants |
Secondary
Number of Subjects With Device-related Complications
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Device-related Complications | 8 Participants |
Secondary
Number of Subjects With Disease Related Mortality
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Disease Related Mortality | 5 Participants |
Secondary
Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture
Time frame: 5 years
Population: Subjects with known exclusion status at 5 years with the following main indications for implantation: Thoracic Aortic Aneurysm, Type B Dissection of the Thoracic Aorta, Traumatic Wound, or Penetrating Aortic Ulcer
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture | 50 Participants |
Secondary
Number of Subjects With Neurological Complications
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Neurological Complications | 13 Participants |
Secondary
Number of Subjects With Secondary Procedures
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Secondary Procedures | 27 Participants |
Secondary
Number of Subjects With Surgical Conversion
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GORE® TAG® Thoracic Endoprothesis | Number of Subjects With Surgical Conversion | 0 Participants |