Publicité
Les langues disponibles
Les langues disponibles
A total of 204 of the 204 enrolled patients in the AMBULATE Trial were evaluable for effectiveness. See Table 4 for definitions of
primary and secondary effectiveness endpoints.
Primary
Time to Ambulation (TTA): elapsed time between removal of the device (i.e. removal of the device for
Effectiveness
VASCADE and removal of the sheath for MC) and when ambulation was achieved (patient standing and walking
Endpoint
at least 6.1 metres without evidence of re-bleeding from the femoral access sites. Per-patient analysis.
Time to Haemostasis (TTH): elapsed time between removal of the device (i.e. removal of the device for VASCADE
and removal of the sheath for MC) and the first observed and confirmed haemostasis). Per-access site analysis.
Total Post Procedure Time (TPPT): elapsed time between removal of the last procedural device/catheter for
the index procedure and when subject is able to successfully ambulate. Per-patient analysis.
Time to Discharge Eligibility (TTDE): elapsed time between final removal of the device (i.e. removal of the
device for VASCADE and removal of the sheath for MC) and when the patient is eligible for hospital discharge
based solely on an assessment of the access site. Per-patient analysis.
Secondary
Time to Discharge (TTD): elapsed time between final removal of the device (i.e. removal of the device for
Effectiveness
VASCADE and removal of the sheath for MC) and hospital discharge. Per-patient analysis.
Endpoints
Total Time to Closure Eligibility (TTCE): elapsed time between removal of the last procedural
device/catheter for the index procedure and the removal of the first VASCADE device (treatment arm) or
removal of the first sheath (control arm). Per-patient analysis.
Procedure Success: Achievement of final haemostasis using any method and freedom from major vascular
complications for 30 days. Per-patient analysis.
Device Success (DS): Successful deployment of the delivery system, delivery of the collagen patch and
achievement of haemostasis with VASCADE alone or with adjunctive compression. Per attempted access site
analysis (treatment arm only).
Primary and secondary effectiveness endpoints are shown in Table 5. The results are:
For the primary ANCOVA model adjusting for the stratification factor, i.e. the number of access sites, the VASCADE MVP
•
treatment effect for TTA compared to MC was -3.32 hours (2.8 ±1.3 hours for VASCADE MVP vs. 6.1 ±1.6 hours for manual
compression; p< 0.0001), indicating VASCADE MVP superiority.
•
TPPT and TTDE demonstrated superiority over manual compression.
•
TTH was noninferior to manual compression per the pre-specified analysis. TTH results implied superiority over manual
compression.
Outcome
Total
TTA (hours)
N
N=100
Mean ± SD
2.8 ± 1.3
Median
2.2
(min, max)
(2.0, 11.5)
TPPT (hours)
N
N=100
Mean ± SD
3.1 ± 1.3
Median
2.6
(min, max)
(2.2, 11.8)
TTH (minutes)
N
N=369
Mean ± SD
6.1 ± 3.7
Median
5.1
(min, max)
(0.4, 33.3)
TTDE (hours)
IFU 5686 AE, 2024-04
Effectiveness Results
Table 4: Effectiveness Endpoint Definitions
Table 5: Primary and Secondary Effectiveness Endpoints
VASCADE MVP
3 Access
4 Access
Sites
Sites
N=31
N=69
2.5 ± 0.8
2.9 ± 1.5
2.2
2.3
(2.0, 5.6)
(2.0, 11.5)
N=31
N=69
2.7 ± 0.8
3.3 ± 1.5
2.4
2.7
(2.2, 5.9)
(2.2, 11.8)
N=93
N=276
5.4 ± 2.0
6.3 ± 4.1
5.1
5.1
(1.3, 23.3)
(0.4, 33.3)
Manual Compression
3 Access
Total
Sites
N=104
N=34
6.1 ± 1.6
5.9 ± 1.2
6.1
5.3
(3.4, 15.7)
(4.2, 9.1)
N=104
N=34
6.8 ± 1.7
6.4 ± 1.3
6.4
6.2
(4.2, 15.9)
(4.5, 9.8)
N=382
N=102
13.7 ± 6.5
11.4 ± 6.4
11.7
10.0
(0.6, 37.1)
(2.9, 32.7)
ANCOVA
Parameter
Estimate
4 Access Sites
(95% CI)
N=70
-3.32
6.2 ± 1.7
(-3.71, -2.92)
6.2
(3.4, 15.7)
N=70
-3.69
6.9 ± 1.9
(-4.10, -3.27)
6.6
(4.2, 15.9)
N=280
GEE Model
-7.5
14.5 ± 6.4
(-8.7, -6.3)
12.5
(0.6, 37.1)
-3.41
P value
<0.0001
<0.0001
<0.0001
Page 7 of 24
Publicité
