Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
14
Table 6. Primary Effectiveness Endpoint
Primary Effectiveness Endpoint % [95% CI]
1
Hypothesis
2
Procedural Success 88.9% [85.5%-
91.6%]
3
H
O
: π
e
≤ 82%
H
A
: π
e
> 82%
1
Clopper-Pearson Exact two-sided 95% confidence interval.
2
π
e
is the probability of the procedural success for OAS device measured by the
success in facilitating stent delivery with < 50% residual stenosis and without in-
hospital MACE.
3
Study conclusions do not change for the worst-case analysis in which all subjects
with missing primary effectiveness endpoint data, and those without post-
procedural CK-MB and troponin data, are treated as having 30-day MACE events.
Table 7 summarizes the components of the primary effectiveness endpoints.
Table 7. Primary Effectiveness Endpoint Components
Criteria Subjects
Subjects with study guide wire crossing lesion and OAD
inserted
N=440
Procedural Success 391/440 (88.9%)
Stent delivered
Yes 430/440 (97.7%)
No 10/440 (2.3%)
Residual stenosis (%)
< 50% Residual Stenosis 434/440 (98.6%)
≥ 50% Residual Stenosis 6/440 (1.4%)
In hospital MACE
Yes 43/440 (9.8%)
No 397/440 (90.2%)
Cardiac Death
No 439/440 (99.8%)
Yes 1/440 (0.2%)
MI
No 399/440 (90.7%)
Yes 41/440 (9.3%)
Target Vessel Revascularization
1
No 437/440 (99.3%)
Yes 3/440 (0.7%)
1
Includes Target Lesion Revascularizations