Aneurysm
Conditions
Brief summary
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) \> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
Interventions
DEVICEGORE CTAG Device
Endovascular aortic stent-graft
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 DTA aneurysm deemed to warrant surgical repair \> * Fusiform (≥50 mm), or \> * Saccular (no diameter criteria)\> 2. Subject is \> 21 years of age\> 3. Proximal and distal landing zone length ≥ 2.0 cm \> * Landing zones must be in native aorta\> * Landing zone may include left subclavian artery, if necessary\> 4. All proximal and distal landing zone inner diameters are between 16-42 mm\> * Diameter assessed by flow lumen and thrombus, if present; calcium excluded\> 5. Life expectancy \> 2 years\> 6. Able to tolerate thoracotomy \> 7. Male or infertile female\> 8. Able to comply with protocol requirements including following-up\> 9. Signed informed consent\>
Exclusion criteria
\> 1. Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper\> 2. Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access\> 3. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)\> 4. Mycotic aneurysm\> 5. Hemodynamically unstable aneurysm rupture\> 6. Aortic dissection\> 7. Planned coverage of left carotid or celiac arteries with the CTAG Device\> 8. Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date\> 9. Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome\> 10. Known history of drug abuse\> 11. ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)\> 12. NYHA class IV \> 13. Participating in another investigational device or drug study within 1 year of treatment\> 14. Subject has known sensitivities or allergies to the device materials\> 15. Subject has a systemic infection and may be at increased risk of endovascular graft infection\>
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment | Treatment through 1 month post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. | Treatment through 1 month post procedure | — |
| Operative Blood Loss (mL) | Initial Device Implant Procedure During Index Hospitalization | Blood loss in mL during initial device implantation procedure |
| Days of Convalescence Stay in an Intensive Care Unit | During the Index Hospitalization | Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation |
| Procedure Time (Minutes) | Initial Device Implant Procedure During Index Hospitalization | Total time in minutes required for surgical device implantation. |
| Time in Days to Return to Normal Daily Activities | Average time within one month window | This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis. |
| Procedural Survival | Initial Device Implant Procedure During Index Hospitalization | Subjects who survived the index procedure |
| Intensive Care Unit (ICU) Stay | Initial Device Implant Index Hospitalization | Subjects admitted to ICU during index hospitalization |
| Total Length of Hospital Stay (Days) | Total Duration of the Index Hospitalization | Total days of hospital stay during the initial hospitalization for implantation of device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE CTAG Device The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | GORE CTAG Device |
|---|---|
| Age, Continuous | 71.9 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 51 |
| other Total, other adverse events | 42 / 51 |
| serious Total, serious adverse events | 37 / 51 |
Outcome results
Primary
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
Time frame: Treatment through 1 month post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTAG Device Aneurysym Subjects | The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment | 50 participants |
p-value: 0.002495% CI: [0.895, 0.996]Binomial Test
Secondary
Days of Convalescence Stay in an Intensive Care Unit
Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Time frame: During the Index Hospitalization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTAG Device Aneurysym Subjects | Days of Convalescence Stay in an Intensive Care Unit | 38 participants |
Secondary
Intensive Care Unit (ICU) Stay
Subjects admitted to ICU during index hospitalization
Time frame: Initial Device Implant Index Hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device Aneurysym Subjects | Intensive Care Unit (ICU) Stay | 38 Participants |
Secondary
Operative Blood Loss (mL)
Blood loss in mL during initial device implantation procedure
Time frame: Initial Device Implant Procedure During Index Hospitalization
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| CTAG Device Aneurysym Subjects | Operative Blood Loss (mL) | 150 mL | Standard Deviation 403.5 |
Secondary
Procedural Survival
Subjects who survived the index procedure
Time frame: Initial Device Implant Procedure During Index Hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CTAG Device Aneurysym Subjects | Procedural Survival | 51 Participants |
Secondary
Procedure Time (Minutes)
Total time in minutes required for surgical device implantation.
Time frame: Initial Device Implant Procedure During Index Hospitalization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CTAG Device Aneurysym Subjects | Procedure Time (Minutes) | 118 Minutes |
Secondary
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Time frame: Treatment through 1 month post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTAG Device Aneurysym Subjects | The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. | 13 participants |
Secondary
Time in Days to Return to Normal Daily Activities
This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Time frame: Average time within one month window
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CTAG Device Aneurysym Subjects | Time in Days to Return to Normal Daily Activities | 31 Days |
Secondary
Total Length of Hospital Stay (Days)
Total days of hospital stay during the initial hospitalization for implantation of device
Time frame: Total Duration of the Index Hospitalization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CTAG Device Aneurysym Subjects | Total Length of Hospital Stay (Days) | 4 Days |