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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P230023 / PAS001 |
| Date Original Protocol Accepted |
01/12/2024
|
| Date Current Protocol Accepted |
|
| Study Name |
Continued Follow-up of the IDE Study Subjects
|
| Device Name |
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
|
| Clinical Trial Number(s) |
NCT05442489
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Assess the safety and effectiveness of the TAMBE Device in the treatment of thoracoabdominal aortic
aneurysms (TAAA) and pararenal aortic aneurysms. This is continued follow up of the premarket cohort.
|
| Study Population |
Subjects with thoracoabdominal or pararenal aortic aneurysms requiring treatment of their adapted Crawford Type IV TAAA and pararenal aneurysms
|
| Sample Size |
142
|
| Key Study Endpoints |
Clinical endpoints include a composite of Uncomplicated Technical Success and Procedural Safety, as well as a composite of Clinically Significant Reintervention and Lesion-related Mortality
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Study provided co-primary safety and effective endpoints:
Uncomplicated Technical Success/Procedural Safety through 1 Month visit = 76.6% (108/141)
Absence of Clinically Significant Reintervention / Lesion related Mortality through 12 Month visit = 72.7% (80/110)
- Rupture = 0.8 % (1/123)
- Lesion Related Mortality = 0.8% (1/124)
Failure of Device Technical Success (SVS Standards) = 0.7% (1/140)
Failure of Clinical success through 12 Month visit = 15.6% (17/109)
Cumulative Mortality through all follow-up = 16.3% (23/141)
Effectiveness Results
Cumulative Reinterventions ([Number of events] subjects)
Procedure = [2] 1.4% (2/141)
1 mo = [4] 2.8% (4/141)
3 mo = [17] 9.3% (13/140)
6 mo = [17] 9.9% (13/131)
12 mo = [29] 15.0% (19/127)
24 mo = [41] 23.7% (27/114)
36 mo = [53] 34.7% (33/95)
48 mo = [55] 53.2% (33/62)
60 mo = [55] 71.7% (33/46)
Aneurysm Growth > 5mm*
1 mo visit = 0.0% (0/131)
3 mo visit = 0.0% (0/19)
6 mo visit = 2.1% (2/97)
12 mo visit = 4.7% (5/106)
24 mo visit = 9.9% (8/81)
36 mo visit = 25.6% (11/43)
48 mo visit = 52.9% (9/17)
*Core lab reported outcomes; follow-up is not complete.
Endoleak new and persistent (Type I | Type III)**
1 mo visit = 2.3% (3/132) | 1.5% (2/132)
3 mo visit = 2.7% (1/37) | 0.0% (0/37)
6 mo visit = 1.0% (1/103) | 0.0% (0/103)
12 mo visit = 1.8% (2/114) | 1.8% (2/114)
24 mo visit = 4.5% (4/89) | 0.0% (0/89)
36 mo visit = 1.9% (1/52) | 0.0% (0/52)
48 mo visit = 0.0% (0/22) | 0.0% (0/22)
60 mo visit = 0.0% (0/2) | 0.0% (0/2)
**site reported outcomes; follow-up is not complete.
Loss of patency in Branch components*
(Celiac | SMA | Left Renal Artery | Right Renal Artery | [evaluable subjects])
1 mo visit = 0.0% (0) | 0.0% (0) | 3.0% (4) | 1.5% (2) | [134]
3 mo visit = 0.0% (0) | 0.0% (0) | 4.7 % (5) | 1.9% (2) | [106]
6 mo visit = 0.9% (1) | 0.0% (0) | 4.7% (5) | 4.7% (5) | [106]
12 mo visit = 1.8% (2) | 0.0% (0) | 6.3% (7) | 7.1% (8) | [112]
24 mo visit = 3.4% (3) | 1.1% (1) | 8.0% (7) | 12.6% (11) | [87]
36 mo visit = 5.7% (3) | 3.8% (2) | 15.1% (8) | 24.5% (13) | [53]
48 mo visit = 8.1% (3) | 5.4% (2) | 21.6% (8) | 35.1% (13) | [37]
60 mo visit = 13.6% (3) | 9.1% (2) | 36.4% (8) | 59.1% (13) | [22]
*Core lab reported outcomes; follow-up is not complete.
Cumulative events* incidence to date through all available follow-up:
Wire fractures ([Number of events] subjects)
[12] 9 Subjects
Device Compression
10.2% (14/137)
Device Migration, Device Kink, Component Separation
[0], 0 Subjects
*Core lab reported outcomes
|
| Actual Number of Patients Enrolled |
141 Subjects in the Primary Study Arm / Continued Access
|
| Actual Number of Sites Enrolled |
44 Sites
|
| Patient Follow-up Rate |
Clinical Follow-up | Follow-up Complete with All Required Imaging
1 mo visit = 95.7% (134/140) | 92.5% (124/134)
3 mo visit = 79.9% (111/139) | 80.2% (89/111)
6 mo visit = 82.6% (109/132) | 78.9% (86/109)
12 mo visit = 90.6% (115/127) | 91.3% (105/115)
24 mo visit = 80.9% (89/110) | 84.3% (75/89)
36 mo visit = 63.5% (54/85) | 79.6% (43/54)
48 mo visit = 53.5% (23/43) | 82.6% (19/23)
60 mo visit = 13.3% (2/15) | 0.0% (0/2)
15 subjects have been lost to follow-up
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