Aortic Aneurysm, Thoracic
Conditions
Brief summary
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
Interventions
implant
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Descending thoracic aortic aneurysm deemed to warrant surgical repair: 1. Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta 2. Saccular aneurysm 2. Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A) 3. 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 4. Life expectancy \> 2 years 5. Surgical Candidate * ASA Class I, II, III, or IV * NYHA Class I, II, III or no heart disease 6. Male or infertile female 7. Minimum 21 years of age 8. Able to comply with protocol requirements 9. Signed Informed Consent Form
Exclusion criteria
1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta 2. Significant thrombus at the proximal or distal implantation zones 3. Mycotic aneurysm 4. Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture) 5. Acute or chronic aortic dissection 6. Planned occlusion of the left carotid or celiac arteries 7. Planned concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days 8. Myocardial infarction or cerebral vascular accident within 6 weeks 9. Severe respiratory insufficiency sufficient that precludes open thoracotomy 10. Renal insufficiency (Creatinine \> 2.0 mg/dL) with or without dialysis 11. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome 12. Participation in another investigational device or drug study within 1 year 13. Documented history of drug abuse within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm Related Death | 5 years | Freedom from aneurysm related mortality for TAG 05-02 subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. | 5 years | Proportion of subjects in TAG 05-02 with MAEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thoracic Endograft GORE TAG® Thoracic Endoprosthesis: implant | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 52 |
| Overall Study | Lost to Follow-up | 28 |
Baseline characteristics
| Characteristic | Thoracic Endograft |
|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 150 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 147 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
Aneurysm Related Death
Freedom from aneurysm related mortality for TAG 05-02 subjects
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Endograft | Aneurysm Related Death | 4 participants |
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
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Endograft | A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair. | 22 participants |