BIOLUX P-IV CHINA ( BIOTRONIK )

NACompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

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.

Trial Locations (1)

200032

Fudan University affiliated Zhongshan Hospital, Shanghai

All Listed Sponsors
lead

Biotronik (Beijing) Medical Device Ltd.

INDUSTRY

NCT02912715 - BIOLUX P-IV CHINA ( BIOTRONIK ) | Biotech Hunter | Biotech Hunter