This trial is active, not recruiting.

Condition peripheral arterial disease (pad)
Treatment zilver® flex™ vascular stent
Sponsor Cook
Start date February 2009
End date November 2011
Trial size 110 participants
Trial identifier NCT00827619, 08-009, 100005, ZBLL


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
single arm non-randomized post-market study
zilver® flex™ vascular stent Stenting
Stenting of the Above-the-Knee Femoropopliteal Artery

Primary Outcomes

Primary patency of the treated lesion within the superficial femoral artery
time frame: 1 year after patient enrollment

Secondary Outcomes

Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement
time frame: 1 year after patient enrollment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery
Principal investigator Jens Ricke, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Cook.