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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® TAG® Thoracic Endoprostheses | Device | Endovascular therapy to treat thoracic disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With All-cause Mortality (Long-term) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture | 5 years | |
| Number of Subjects With Neurological Complications | 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.
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| Name | Affiliation | Role |
|---|---|---|
| Nabil Chakfé, Prof | Hôpitaux Universitaire de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopitaux Universitaire de Strasbourg | Strasbourg | 67091 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With All-cause Mortality (Long-term) | Posted | Count of Participants | Participants | 5 years |
|
|
Five year follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GORE® TAG® Thoracic Endoprothesis | GORE® TAG® and Conformable GORE® TAG® Thoracic Endoprosthesis Registiry conducted for reimbursement in France and no MedDRA coding was required. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charee Robe, Biostatistician | W.L. Gore & Associates | 928-864-4048 | crobe@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2015 | Nov 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2017 | Dec 12, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094629 | Dissection, Thoracic Aorta |
| D001018 | Aortic Diseases |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Number of Subjects With Cardiac, Renal, and Pulmonary Complications |
| 5 years |
| Number of Subjects With Device-related Complications | 5 years |
| Number of Subjects With Surgical Conversion | 5 years |
| Number of Subjects With Secondary Procedures | 5 years |
| Number of Subjects With Disease Related Mortality | 5 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Main Indication for Implantation | Count of Participants | Participants |
|
|
| Secondary | Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture | 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 | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Subjects With Neurological Complications | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Subjects With Cardiac, Renal, and Pulmonary Complications | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Subjects With Device-related Complications | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Subjects With Surgical Conversion | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Subjects With Secondary Procedures | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Number of Subjects With Disease Related Mortality | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 31 |
| 154 |
| 79 |
| 154 |
| 38 |
| 154 |
| Neurological | Nervous system disorders | Non-systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Renal | Renal and urinary disorders | Non-systematic Assessment |
|
| Vascular | Vascular disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
|
| Neurological | Nervous system disorders | Non-systematic Assessment |
|
| Renal | Renal and urinary disorders | Non-systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
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| D000784 |
| Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |