NCT05435716

Clinical Trial of C-Wave™ Peripheral Lithoclasty System Catheter System

Efficacy and Safety Trial of C-wave™ Peripheral Lithoclasty Catheter System in Peripheral Arterial Angioplasty

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Suzhou Zhonghui Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of peripheral shock catheter system in peripheral arterial angioplasty.This trial is a prospective, multicenter, open, randomized, parallel controlled and superior clinical trial. Select ≥3 hospitals with the qualification of national clinical trial institutions as clinical trial centers, and plan to enroll a total of 120 subjects. The ratio of subjects in the trial group and the control group is 1: 1 (60 in the trial group and 60 in the control group). This study mainly includes four stages: the screening (baseline) period (-14 \~0 days), the operation day (the day of treatment), the postoperative visit (0\~7days ) and the 30-day follow-up (30 ±7days ).

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	C-wave™ peripheral seismic waveguide system	In the experimental group, if the target lesions did not show flow-limiting dissection or severe elastic retraction, drug-coated balloon was subsequently performed after lumen preparation by peripheral seismic catheterization system (IVL). If there is limited flow dissection or severe elastic retraction, stent therapy is followed.
DEVICE	Peripheral vascular balloon dilatation catheter (PTA)	Subjects in the control group received balloon dilatation catheter in peripheral blood for lumen preparation, and if the target lesions did not show flow-limiting interlayer or severe elastic retraction, drug-coated balloon therapy was subsequently performed. If there is limited flow dissection or severe elastic retraction, stent therapy is followed.

Timeline

• Start date: 2021-08-05
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2022-06-28
• Last updated: 2022-09-22

Locations

1 site across 1 country: China