COOK Medical Zilver, Инструкция по эксплуатации

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Table 6: Rates for All Major Adverse Events within 9 Months Post-Procedure
Pivotal Study Result OPC
Point Estimate
2-sided 95% CI
Upper Bound
Target Value Upper Limit
All enrolled patients 1 16/151 (10.6%) 16.6%
16% 25% Evaluable patients 2 11/146 (7.5%) 13.1%
1 5 patients who could not be assessed at 9 months (i.e., 1 withdrawn and 4 lost to follow-up) were imputed as
experiencing MAE as a worst case analysis.
2 Major adverse events in 7 of the 11 patients reported with MAE were adjudicated by an independent Clinical Events
Committee as not related to the device or the procedure.
Effectiveness of the Zilver Vascular Stent was confirmed by clinical and imaging assessment
post-procedure and at follow-up time points. Effectiveness measures included acute procedure
success, 30-day clinical success, ankle-brachial index, patency, and 9-month functional status
measured by the walking impairment questionnaire. These measures are summarized in Table 7.
Table 7: Effectiveness Measures for Patients Implanted with the Zilver Vascular Stent
Effectiveness
Measure Pre-Procedure Post-Procedure One-Month Nine-Month
Acute Procedure
Success
93.3%
(140/150)
1
30-day Clinical
Success 94.0% (141/150)
ABI 2
0.68 ± 0.23
(N=154)
0.88 ± 0.29
(N=152)
0.86 ± 0.20
(N=140)
0.87 ± 0.21
(N=137)
Patency of Stented
Lesion 99.2% (123/124)
92.9%
(105/113)
Walking Distance
Score
20.1 ± 28.8
(N=147)
63.5 ± 38.3
(N=138)
55.8 ± 40.1
(N=124)
Walking Speed
Score
25.6 ± 29.2
(N=141)
63.1 ± 37.4
(N=131)
56.7 ± 37.5
(N=119)
1 One patient was excluded from the analysis due to placement of a non-study stent during the procedure.
2
There were 177 treated lesions in the study that occurred in 170 limbs.
N = number of limbs treated.