Peripheral Artery Disease
Conditions
Keywords
Zilver® PTX® Drug-Eluting Peripheral Stent, Above-the-Knee Femoropopliteal Artery, Chinese patient
Brief summary
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
Interventions
Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4 * Stenotic (\>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery * Reference vessel diameter of 4-9 mm * Lesion length up to 140 mm
Exclusion criteria
* Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure * Previous stent in the study vessel * Bypass graft with an anastomosis in the study vessel * Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion * No patent vessel of runoff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency as Assessed by Duplex Ultrasonography | 12 months |
Countries
China
Outcome results
None listed