|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|
Umair Qazi, M.D., MPH
|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:|
|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
|Anticipated End Date:||2012|
|Compensation for Participating:||None|