158
Participants
Start Date
October 31, 2016
Primary Completion Date
August 31, 2020
Study Completion Date
August 31, 2020
Paclitaxel releasing angioplasty balloon
Paclitaxel releasing angioplasty balloon catheter is advanced through an introducer sheath and tracked over the wire until reaching the target lesion. The balloon can be precisely positioned by means of the radiopaque markers crimped on the inner shaft of the catheter. The catheter is dilated up to its intended diameter by inflating the balloon with a solution containing contrast media, causing a compression of the arterial plaque against the inner lining of the arterial wall and improving blood flow. After balloon inflation, the drug-carrier adheres to the arterial wall and facilitates the drug release to surrounding tissue. As there is no need for sustained release of Paclitaxel after the inflation, the drug carrier dissolves rapidly.
Fudan University affiliated Zhongshan Hospital, Shanghai
Biotronik (Beijing) Medical Device Ltd.
INDUSTRY