Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE TAG® Thoracic Endoprosthesis | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE TAG® Thoracic Endoprosthesis | Device | implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aneurysm Related Death | Freedom from aneurysm related mortality for TAG 05-02 subjects | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. | Proportion of subjects in TAG 05-02 with MAEs | 5 years |
Not provided
Inclusion Criteria:
Descending thoracic aortic aneurysm deemed to warrant surgical repair:
Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)
Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm
• <60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment
Life expectancy > 2 years
Surgical Candidate
Male or infertile female
Minimum 21 years of age
Able to comply with protocol requirements
Signed Informed Consent Form
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Morasch, M.D. | St. Vincent's Healthcare, Billings MT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Thoracic Endograft | GORE TAG® Thoracic Endoprosthesis: implant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| United States |
| San Francisco | California | United States |
| Greeley | Colorado | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Chicago | Illinois | United States |
| Peoria | Illinois | United States |
| Kansas City | Kansas | United States |
| New Orleans | Louisiana | United States |
| Boston | Massachusetts | United States |
| St Louis | Missouri | United States |
| Albany | New York | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Memphis | Tennessee | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Temple | Texas | United States |
| Salt Lake City | Utah | United States |
| Charlottesville | Virginia | United States |
| Seattle | Washington | United States |
| Vancouver | Washington | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Thoracic Endograft | GORE TAG® Thoracic Endoprosthesis: implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Aneurysm Related Death | Freedom from aneurysm related mortality for TAG 05-02 subjects | Posted | Number | participants | 5 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. | Proportion of subjects in TAG 05-02 with MAEs | Posted | Number | participants | 5 years |
|
|
|
Total Study Follow-up.
Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0502 TAG Device Subjects | 0 | 150 | 147 | 150 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding Complication | Blood and lymphatic system disorders |
| |||
| Cardiac Complication | Cardiac disorders |
| |||
| Bowel Complication | Gastrointestinal disorders |
| |||
| Additional Implantation | General disorders |
| |||
| Other Complication | General disorders |
| |||
| Endoleak | Injury, poisoning and procedural complications |
| |||
| Wound Complication | Injury, poisoning and procedural complications |
| |||
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Neurologic Complication | Nervous system disorders |
| |||
| Genitourinary | Renal and urinary disorders |
| |||
| Renal Function Complication | Renal and urinary disorders |
| |||
| Pulmonary Complication | Respiratory, thoracic and mediastinal disorders |
| |||
| Vascular Complication | Vascular disorders |
|
Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Makowsky | W. L. Gore and Associates, Inc. | 6232345784 | rmakowsk@wlgore.com |
| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
| Categories |
|---|
|