Zilver® Flex™ Vascular Stent Study

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease (PAD)
• Interventions: Device: Zilver® Flex™ Vascular Stent

• Registration Number: NCT00827619
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Study Start: 2009-02
• Primary Completion: 2011-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Zilver® Flex™ Vascular Stent	single arm non-randomized post-market study

Primary Outcome Measures

Name	Time	Method
Primary patency of the treated lesion within the superficial femoral artery	1 year after patient enrollment

Secondary Outcome Measures

Name	Time	Method
Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement	1 year after patient enrollment

Trial Locations

Locations (3)

Herz-Zentrum; 🇩🇪 Bad Krozingen, Germany

Universitatsklinikum Magdeburg; 🇩🇪 Magdeburg, Germany

Gemeinschaftspraxis; 🇩🇪 Leipzig, Germany