Zilver PTX

Summary of Trial:	This investigation will compare the long-term (12-month) safety and effectiveness of the Zilver® PTX™ Drug-Eluting Vascular Stent to Control (PTA) in a multicenter clinical trial involving up to 56 investigative sites. Patients with de novo or restenotic lesions of the above-the-knee femoropopliteal artery that have not been previously stented will be eligible to be randomly assigned to either the Zilver® PTX™ Drug-Eluting Vascular Stent group or the Control group. A single lesion in each limb (total of two lesions per patient) may be treated. Results from this study will be used to evaluate the short-term (1 year) primary study outcome which is needed to evaluate safety and performance of this device and to support submission of marketing approval. When the last enrolled patient completes 1-year follow-up, a regulatory submission for marketing approval (e.g., Shonin and PMA) will be prepared. Longer term (5-year) follow-up data will be collected to provide valuable information on late adverse events and device integrity.
Principal Investigator:	Mahmoud B Malas, M.D., MHS, FACS
Study Coordinator:	Umair Qazi, M.D., MPH Email: uqazi1@jhmi.edu
Study Long Title:	Evaluation of the Zilver PTX TM Vascular Stent in the Above-the-Knee Femoropopliteal Artery Clinical Study Protocol
Study Short Title:	Zilver PTX
JHU IRB Number:	NA_00012837
Funding Source:	Cook Incorporated
Clinical Trial Site:	The study enrolled patients in multiple sites across the U.S. Enrollment is now closed. Patients are in currently in follow-up. Johns Hopkins Bayview Medical Center 4940 Eastern Ave Baltimore MD 21224
Start Date:	2007
Anticipated End Date:	2012
Compensation for Participating:	None