Aortic Aneurysm, Thoracic
Conditions
Brief summary
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
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. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair * Fusiform (≥50 mm), or * Saccular (no diameter criteria) 2. All proximal and/or all distal landing zone inner diameters between 37-42 mm * Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications 3. Proximal and distal landing zone length greater than 2.0 cm * Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed 4. Life expectancy \> 2 years 5. Subject is open surgical candidate defined as: * Able to tolerate thoracotomy * American Society of Anesthesiologists class I-IV (class V excluded) * New York Heart Association class I-III or not applicable (class IV excluded) 6. Male or infertile female 7. Age greater than 21 years 8. Able to comply with study protocol requirements, including follow-up
Exclusion criteria
1. Mycotic aneurysm 2. Hemodynamically unstable aneurysm rupture 3. Aortic dissection 4. Planned occlusion of left carotid or celiac arteries 5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date 6. Myocardial infarction or stroke within 6 weeks of treatment 7. Pre-treatment creatinine \> 2.0 mg/dL 8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 9. Participation in another drug or device study within 1 year of treatment 10. History of drug abuse within 6 months of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment | one year | Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (\>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 45mm TAG Device Subjects The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true line extension, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Subject refuses to follow up or return. | 5 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | 45mm TAG Device Subjects |
|---|---|
| Age, Continuous | 77.6 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 23 |
| serious Total, serious adverse events | 17 / 23 |
Outcome results
Primary
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (\>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 45mm TAG Device Subjects | Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment | 11 Participants |