Peripheral Arterial Disease (PAD)
Conditions
Keywords
Peripheral Arterial Disease
Brief summary
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.
Interventions
DEVICEZilver® Flex™ Vascular Stent
Stenting 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
* Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment. * To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.
Exclusion criteria
* Patient is \< 18 years of age. * Patient is pregnant or breast-feeding. * Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study. * Patient has had previous stenting of the target vessel. * Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis. * Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated. * Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. * Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency of the treated lesion within the superficial femoral artery | 1 year after patient enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement | 1 year after patient enrollment |
Countries
Germany
Outcome results
None listed