Zilver® Flex™ Vascular Stent Study

Overview

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.

Full Title of Study: “Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2011

Interventions

  • Device: Zilver® Flex™ Vascular Stent
    • Stenting of the Above-the-Knee Femoropopliteal Artery

Arms, Groups and Cohorts

  • Other: 1
    • single arm non-randomized post-market study

Clinical Trial Outcome Measures

Primary Measures

  • Primary patency of the treated lesion within the superficial femoral artery
    • Time Frame: 1 year after patient enrollment

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Group Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jens Ricke, MD, Principal Investigator, Universitatsklinikum Magdeburg

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