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Outcome
Total
N
N=100
Mean ± SD
3.1 ± 1.3
Median
2.5
(min, max)
(2.3, 11.7)
TTD (hours)
N
N=100
Mean ± SD
21.8 ± 13.4 20.5 ± 10.8 22.3 ± 14.5
Median
22.3
(min, max)
(2.3, 96.1)
TTCE (minutes)
N
N=100
Mean ± SD
10.5 ± 6.0
Median
10.1
(min, max)
(1.7, 47.5)
*per protocol, TTCE is only descriptively summarised without hypothesis testing.
Proportions of subjects achieving TTA at various fixed time points during the AMBULATE Trial are shown in Table 6.
Table 6: Proportion of Patients Achieving Ambulation at Fixed Time Points (Per-Patient Analysis)
Time Point
≤ 1 hours
≤ 2 hours
≤ 3 hours
≤ 4 hours
≤ 5 hours
≤ 6 hours
≤ 7 hours
≤ 8 hours
≤ 9 hours
≤ 10 hours
≤ 12 hours
≤ 24 hours
Table 7 shows the proportion of subjects achieving Device Success. Device issues were limited to known device performance issues
based on VASCADE MVP product family such as device pull-through, inability to deploy disc, inability to achieve temporary haemostasis
and use error.
Device Success
Per Intent to Treat*
Actual Devices Attempted
*Note: 6 device access sites switched to manual compression.
IFU 5686 AE, 2024-04
VASCADE MVP
3 Access
4 Access
Sites
Sites
N=31
N=69
2.7 ± 0.8
3.2 ± 1.5
2.5
2.6
(2.3, 5.9)
(2.3, 11.7)
N=31
N=69
22.9
22.3
(2.3, 48.2)
(3.5, 96.1)
N=31
N=69
9.0 ± 4.1
11.1 ± 6.6
9.8
10.2
(1.7, 17.5)
(2.0, 47.5)
VASCADE MVP (N=100)
0
1
78
84
93
98
99
99
99
99
100
100
Table 7: VASCADE MVP Device Success (Device Arm Only) Per Access Site
Manual Compression
3 Access
Total
Sites
N=104
N=34
6.5 ± 1.9
6.2 ± 1.3
6.3
5.7
(4.3, 21.3)
(4.6, 9.4)
N=104
N=34
21.8 ± 9.5
22.7 ± 10.6
22.1
22.8
(5.7, 72.9)
(5.7, 71.5)
N=104
N=34
37.6 ± 33.2
32.2 ± 27.6
25.2
21.1
(1.8, 132.3)
(2.0, 108.9)
0%
1%
78%
84%
93%
98%
99%
99%
99%
99%
100%
100%
Number of Access Sites
369
363
Parameter
Estimate
4 Access Sites
(95% CI)
(-3.87, -2.96)
N=70
6.6 ± 2.2
6.5
(4.3, 21.3)
N=70
-0.04
21.4 ± 9.0
(-3.25, 3.17)
21.6
(5.8, 72.9)
N=70
-
40.3 ± 35.5
27.8
(1.8, 132.3)
MC (N=104)
0
0%
0
0%
0
0%
1
1%
18
17%
48
46%
87
84%
93
89%
100
96%
103
99%
103
99%
104
100%
Successes
351
351
ANCOVA
P value
0.98
-
Percent
95%
97%
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