Spectranetics AngioSculpt X Mode D'emploi page 7

Table 5: Adjudicated Death, Myocardial Infarction, Coronary
Revascularization, and Stent Thrombosis up to 24 months,
ITT population
Bare
Clinical Endpoint Balloon,
Event N = 28
patients
Events Through 6 Months Events Through 6 Months Events Through 6 Months Events Through 6 Months Events Through 6 Months
Any Stent Thrombosis 0
Any Death 1 (3.6%)
Cardiac 0
Non-Cardiac 1 (3.6%)
Any MI 2 (7.1%)
Target Vessel MI 2 (7.1%)
Non-target vessel MI 0
Clinically driven TLR 9 (32.1%)
Clinically driven TVR† 10 (35.7%)
Any revascularization‡ 12 (42.9%) Any revascularization‡
Events Through 12 Months Events Through 12 Months Events Through 12 Months Events Through 12 Months Events Through 12 Months
Any Stent Thrombosis 0
Any Death 1 (3.6 %)
Cardiac 0
Non-Cardiac 1 (3.6 %)
Any MI 2 (7.4 %)
Target Vessel MI 2 (7.4 %)
Non-target Vessel MI 0
Clinically driven TLR 9 (33.3 %)
Clinically driven TVR† 10 (37.0 %) 27
Any revascularization‡ 12 (44.4 %) 27 Any revascularization‡
Events Through 24 Months
Any Stent Thrombosis 0
Any Death 1 (3.6 %)
Cardiac 0
Non-Cardiac 1 (3.6 %)
Any MI 3 (11.1 %)
Target Vessel MI 3 (11.1 %)
Non-target Vessel MI 0
Clinically driven TLR 9 (33.3 %)
Clinically driven TVR† 10 (37.0 %) 27
Any revascularization‡ 12 (44.4 %) 27 Any revascularization‡
Values are n(%)
* Number of patients with available data/in denominator for calculation.
For example, 12 month rates in the bare group, one patient died (cardiac)
prior to 6 month follow-up, therefore n = 27 except for any/non-cardiac
death, which is n = 28. For the 12 month rates in the coated group,
one patient with no 12 month follow-up and another patient with cardiac
death, non-TV-MI, and any revascularization; therefore, n =32 for those
parameters and n = 31 for the remaining parameters.
†TVR includes TVR/non-TLR and TLR
‡Any revascularization included patients with TLR, TVR, and non-TVR
P009923-D 22NOV19 (2019-11-22)
Paclitaxel-
Coated
Balloon, p-value
(n)* (n)*
N = 33
patients
28 0 33
28 1 (3.0%) 33 1.0
28 1 (3.0%) 33 1.0
28 0 33 0.46
28 1 (3.0%) 33 0.6
28 0 33 0.21
28 1 (3.0%) 33 1.0
28 1 (3.0%) 33 0.004
28 1 (3.0%) 33 0.0016
28 6 (18.2%) 33 0.05
27 1 (3.2%) 31 1.0
28 2 (6.3 %) 32 1.0
27 2 (6.3 %) 32 0.5
28 0 31 0.47
27 2 (6.3 %) 32 1.0
27 1 (3.2%) 31 0.6
27 1 (3.1 %) 32 1.0
27 1 (3.2%) 31 0.004
1 (3.2%) 31 0.0016
7 (21.9 %) 32 0.094
27 1 (3.2%) 31 1.0
28 3 (9.4 %) 32 0.6
27 2 (6.3 %) 32 0.5
28 1 (3.3%) 30 1.0
27 2 (6.3 %) 32 0.7
27 1 (3.2%) 31 0.3
27 1 (3.2 %) 31 1.0
27 1 (3.3%) 30 0.004
2 (6.7%) 30 0.008
7 (22.6 %) 31 0.097
Table 6: Adjudicated Death, Myocardial Infarction, Coronary
Revascularization, and Stent Thrombosis up to 24 months,
PP population
Clinical Endpoint
Event
- Any Stent Thrombosis
Any Death
Cardiac
Non-Cardiac
Any MI
Target Vessel MI
Non-target vessel MI
Clinically driven TLR
Clinically driven TVR†
Any revascularization‡ Any revascularization‡ 12 (42.9%)
Any Stent Thrombosis
Any Death
Cardiac
Non-Cardiac
Any MI
Target Vessel MI
Non-target Vessel MI
Clinically driven TLR
Clinically driven TVR†
Any revascularization‡ 12 (44.4 %) Any revascularization‡
Any Stent Thrombosis
Any Death
Cardiac
Non-Cardiac
Any MI
Target Vessel MI
Non-target Vessel MI
Clinically driven TLR
Clinically driven TVR†
Any revascularization‡ 12 (44.4 %) Any revascularization‡
Values are n(%)
* Number of patients with available data/in denominator for calculation.
For example,12 month rates in the bare group, one patient died (cardiac)
prior to 6 month follow-up, therefore n = 27 except for any/non-cardiac
death, which is n = 28. For the 12 month rates in the coated group, one
patient with no 12 month follow-up and another patient with cardiac
death, non-TV-MI, and any revascularization; therefore, n = 29 for those
parameters and n = 28 for the remaining parameters.
†TVR includes TVR/non-TLR and TLR
‡Any revascularization included patients with TLR, TVR, and non-TVR
MATERIALS REQUIRED FOR USE WITH THE ANGIOSCULPT®X
CATHETER
WARNING - Use single use items only. Do not resterilize or reuse.
• Femoral, brachial or radial guiding catheter (≥ 6F)
• Hemostatic valve
• Contrast medium diluted 1:1 with normal saline
• Sterile heparinized normal saline
• 10cc and 20cc syringes for ushing and balloon prep
• In ation device (inde ator)
• 0.014" coronary guide wire
• Guide wire introducer
• Guide wire torque device
• Radiographic contrast
• Manifold (for pressure monitoring and contrast injection),
extension pressure tubing
Paclitaxel-
Bare
Coated
Balloon,
Balloon,
N = 28 (n)*
N = 30
patients
patients
Events Through 6 Months Events Through 6 Months Events Through 6 Months Events Through 6 Months Events Through 6 Months
0 28 0
1 (3.6%) 28 1 (3.3%)
0 28 1 (3.3%)
1 (3.6%) 28 0
2 (7.1%) 28 1 (3.3%)
2 (7.1%) 28 0
0 28 1 (3.3%)
9 (32.1%) 28 0
10 (35.7%) 28 0
28 5 (16.7%)
Events Through 12 Months Events Through 12 Months Events Through 12 Months Events Through 12 Months Events Through 12 Months
0 27 1 (3.6%)
1 (3.6 %) 28 2 (6.9 %)
0 27 2 (6.9 %)
1 (3.6 %) 28 0
2 (7.4 %) 27 2 (6.9 %)
2 (7.4 %) 27 1 (3.6%)
0 27 1 (3.5 %)
9 (33.3 %) 27 0
10 (37.0 %) 27 0
27 6 (20.7 %)
Events Through 24 Months Events Through 24 Months Events Through 24 Months Events Through 24 Months Events Through 24 Months
0 27 1 (3.6%)
1 (3.6 %) 28 3 (10.3 %)
0 27 2 (6.9 %)
1 (3.6 %) 28 1 (3.7%)
3 (11.1 %) 27 2 (6.9%)
3 (11.1 %) 27 1 (3.6%)
0 27 1 (3.6 %)
9 (33.3 %) 27 0
10 (37.0 %) 27 1 (3.7%)
27 6 (21.4 %)
p-value
(n)*
30 -
30 1.0
30 1.0
30 0.48
30 0.61
30 0.23
30 1.0
30 0.0006
30 0.0003
30 0.04
28 1.0
29 1.0
29 0.5
28 1.0
29 1.0
28 0.6
29 1.0
28 0.0007
28 0.0003
29 0.09
28 1.0
29 0.6
29 0.5
27 1.0
29 0.7
28 0.4
28 1.0
27 0.002
27 0.005
28 0.09
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