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The baseline demographic and clinical characteristics of the 2 treatment groups were similar (Table 2).
Table 2: AMBULATE Study Population, Baseline and Procedure Characteristics
Number of subjects (204 total)
Age (years), mean
BMI (kg/m
2
), mean
Female (%)
Administration of anticoagulant/antiplatelet drugs within 24 hours before the procedure
Intraoperative administration of heparin
Protamine used (heparinised subjects)
Activated clotting time (ACT) (seconds) at the end of the catheterisation
procedure (heparinised subjects), mean
The primary and secondary safety endpoints were the rates of access site-related major and minor complications during follow-up
(Table 3). The major complication rates were clinically the same (0%) for VASCADE MVP and Manual Compression (MC). The
VASCADE MVP minor complication rate was numerically lower than for MC and clinically similar.
Table 3: AMBULATE As-Reported Major and Minor Closure-Related Complications, Number of Limbs with Each Event
Access Site Closure-Related Complications at 30 Days by Event
Any major venous access site closure-related complication
Access site bleeding requiring transfusion
Vascular injury requiring surgical repair
Access site infection confirmed and requiring intravenous antibiotics and/or prolonged
hospitalisation
New onset permanent access site-related nerve injury (i.e. persisting for > 30 days)
New onset access site-related nerve injury in the ipsilateral lower extremity requiring
surgical repair
Pulmonary embolism requiring surgical or endovascular intervention and/or resulting
in death
Pulmonary embolism NOT requiring surgical or endovascular intervention and/or NOT
resulting in death
Any Minor Venous Access Site Closure-Related Complication
Bleeding from the access site requiring > 30 minutes of continual manual compression
to achieve initial venous haemostasis
Access site-related haematoma > 6 cm documented by ultrasound
Delayed bleeding from the access site (following hospital discharge)
Ipsilateral deep vein thrombosis, confirmed by ultrasound/imaging
Localised access site infection confirmed and treated with intramuscular or oral
antibiotics
Arteriovenous fistula requiring treatment
Arteriovenous fistula not requiring treatment
Pseudoaneurysm requiring thrombin/fibrin adhesive injection or ultrasound-guided
compression
Pseudoaneurysm not requiring treatment
Access site-related vessel laceration
Access site wound dehiscence
Transient access site-related nerve injury
IFU 5686 AE, 2024-04
Safety Results
VASCADE MVP
100
61.5 ± 11.6
63.4 ± 11.1
29.5
29.7
33%
38%
84%
85%
85%
90%
92%
91%
298.6
285.9
VASCADE MVP
MC
(N=199)
(N=209)
0
0.0%
0
0
0.0%
0
0
0.0%
0
0
0.0%
0
0
0.0%
0
0
0.0%
0
0
0.0%
0
0
0.0%
0
2
1.0%
5
0
0.0%
0
0
0.0%
2
0
0.0%
0
0
0.0%
0
1
0.5%
1
0
0.0%
0
0
0.0%
1
1
0.5%
0
0
0.0%
0
0
0.0%
0
0
0.0%
0
0
0.0%
1
Page 6 of 24
MC
104
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
0.0%
2.4%
0.0%
1.0%
0.0%
0.0%
0.5%
0.0%
0.5%
0.0%
0.0%
0.0%
0.0%
0.5%
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