The case was performed by one of the study’s principal investigators, Peng Liu, professor at the China-Japan Friendship Hospital in Beijing, China.
“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,” said Liu.
The study will evaluate the performance of the Zilver PTX stent to treat peripheral artery disease (PAD) in the superficial femoral artery in Chinese patients. Chinese patient outcome data will be compared to patient results shown in Cook’s global randomised clinical study of the device. The study is a pre-market requirement of the China Food and Drug Administration (CFDA). Data collected will be submitted to CFDA in support of commercial registration of Zilver PTX in China.
The study, the first of its kind in China, is being conducted at up to 20 clinical sites and will enroll 175 patients with one-year follow-up. Study leaders include global principal investigator Michael Dake, M of Stanford University, Stanford, USA, and co-national principal investigators Changwei Liu, of Peking Union Medical College Hospital in Beijing, and Weiguo Fu, of Zhongshan Hospital Fudan University in Shanghai. A total of six patients at two sites are now enrolled in the study.
Zilver PTX is indicated for treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries having a reference vessel diameter from 4– 9mm. To date, the device has been studied clinically in more than 2,200 patients worldwide. Zilver PTX is approved for commercial sale in the USA, Japan, Europe, Canada, Australia, Brazil, India and other markets.