Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device

NANot yet recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2027

Conditions
Coronary Arterial Disease
Interventions
DEVICE

Intravascular Lithotripsy

study group will receive the investigational devices (Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy Device) for calcified lesion pre-treatment.

DEVICE

Rotational Atherectomy

control group will receive the control device (Coronary Rotational Atherectomy System)

Trial Locations (1)

200032

Zhongshan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Spectrumedics Medical Technology(Shanghai)Co.,Ltd

INDUSTRY

NCT07109479 - Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device | Biotech Hunter | Biotech Hunter