Cook Medical Begins Enrollment of Zilver PTX Trial in China

August 15, 2014—Cook Medical announced that it has enrolled the first patient in the clinical study in China of its Zilver PTX paclitaxel-eluting peripheral stent. The first case was performed by one of the study’s Principal Investigators Prof. Peng Liu, MD, at the China-Japan Friendship Hospital in Beijing. Six patients at two sites have been enrolled in the study, noted the company.

The company advised that the study will evaluate the performance of the Zilver PTX stent to treat peripheral artery disease in the superficial femoral artery in Chinese patients. These patient outcome data will be compared to patient results from Cook’s global randomized clinical study of the device. The study is a premarket requirement of the China Food and Drug Administration. Data collected will be submitted to the agency in support of commercial registration of Zilver PTX in China.

According to Cook Medical, the study is the first of its kind in China. It is being conducted at up to 20 clinical sites and will enroll 175 patients through 1-year follow-up. The study’s Global Principal Investigator is Michael Dake, MD, of Stanford University in Stanford, California. In China, the Co-National Principal Investigators are Changwei Liu, MD, of Peking Union Medical College Hospital in Beijing, and Weiguo Fu, MD, of Zhongshan Hospital Fudan University in Shanghai. 

Prof. Liu commented in Cook’s press release, “It’s great to have enrolled the first case of Zilver PTX China clinical trial by our center. The product represents the latest drug technology in the peripheral vascular system. We are looking forward to bringing this new technology to Chinese patients to overcome the troublesome restenosis problem.”

Cook’s Zilver PTX peripheral stent is indicated for treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries having a reference vessel diameter from 4 to 9 mm. Zilver PTX is approved for commercial sale in the United States, Japan, Europe, Canada, Australia, Brazil, India, and other markets, noted the company.