Clinical evaluation of the performance and safety of the Zilver PTX stent thumbwheel delivery system in the treatment of symptomatic peripheral arterial disease of the above-the-knee femoropopliteal arteries.

Cook Incorporated0 sites45 target enrollmentMay 13, 2014

Overview

No summary available.

Registry

who.int

Start Date

May 13, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:
•1\. One atherosclerotic lesion of the above\-the\-knee femoropopliteal artery with \>50% angiographically\-documented stenosis
•2\. Reference vessel diameter of 4\-7 mm
•3\. Symptomatic for peripheral arterial disease classified as Rutherford Category 2\-4

•Patients are excluded from enrollment into the study if any of the following are true:
•General Exclusion Criteria
•1\. Unable or unwilling to sign and date informed consent
•2\. Less than 18 years of age
•3\. Unable or unwilling to comply with follow\-up schedule
•4\. Simultaneous participation in another 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.
•5\. Pregnant, breastfeeding or planning to become pregnant in the next 5 years.
•6\. Medical condition or disorder that would limit life expectancy \< 30 days
•7\. Prior stent in the study vessel
•8\. Underwent any surgical or interventional procedure within 30 days prior to the study procedure.