COOK Medical Zilver, Инструкция по эксплуатации

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at 9 months included measurement of ABI on the treated side as well as completion of the
walking impairment questionnaire, and an ultrasound to evaluate patency. In addition,
patients were contacted by telephone at 6 months post-procedure. All data were recorded
on case report forms at the investigative sites. Independent core laboratories were to analyze
angiographic and ultrasonic imaging.
Results
The primary study endpoint is the major adverse event (MAE) rate occurring within nine
months post-procedure. Major adverse events include death, MI (non-Q-wave and Q-wave),
target lesion revascularization, and limb loss on the same side as the treated lesion. Success
of the study required that the MAE rate be less than or equal to a predetermined objective
performance criterion (OPC) of 16%. All MAEs were also adjudicated with respect to their
relationship to the study device by an independent Clinical Events Committee.
Table 4 presents the adverse events and complications reported in the pivotal study. Events
that occurred while the patients were hospitalized and cumulative events through 9 months
post-implant are presented. There were a total of 8 deaths, 3 myocardial infarctions (MI), 1
target lesion revascularization, and 1 limb loss. Two patients experienced 2 events each as
discussed below. All patients have completed their 9-month follow-up or reached a study
endpoint. Five (5) of the 151 patients (3.3%) have been confirmed as withdrawn or lost to
follow-up. Therefore, there were 146 evaluable patients available for assessment of MAE within
the entire 9-month follow-up period. This number (146) exceeds the sample size of 130 patients
determined a priori to be necessary to provide at least 80% power for this measure.
Table 4: Adverse Events/Complications Observed in Patients Implanted with the Zilver®
Vascular Stent
Adverse Event/Complication In-Hospital
Cumulative thru
9 Months
Death
(1)
2.6% (4/151) 5.3% (8/151)
MI (Non-Q-Wave and Q-Wave)
(1)
0.7% (1/151) 2.0% (3/151)
Target Lesion Revascularization 0.0% (0/151) 0.7% (1/151)
Limb Loss (1) 0.0% (0/151) 0.7% (1/151)
Arterial Aneurysm/Rupture 0.0% (0/151) 0.0% (0/151)
Blood Loss Requiring Transfusion 3.3% (5/151) 4.6% (7/151)
Blue Toe Syndrome 0.0% (0/151) 0.7% (1/151)
Drug/Allergic Reactions Requiring Antibiotics 0.7% (1/151) 0.7% (1/151)
Embolism 0.0% (0/151) 0.0% (0/151)
Hematoma at Access Site Requiring
Intervention 1.3% (2/151) 1.3% (2/151)
Hemorrhagic Stroke with Deficit 0.0% (0/151) 0.0% (0/151)
Iliac Artery Spasm 0.0% (0/151) 0.0% (0/151)