NCT05434676

SOLUTION Trial in China

Clinical Trial of The ShOckwave Medical Peripheral Lithoplasty® System Used to Treat Moderate and Severely CalcIfied FemOropopliteal Arteries in ChiNese Patients (SOLUTION Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Genesis Medtech Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients

Conditions

• Peripheral Arterial Disease
• Calcifications Vascular

Interventions

Type	Name	Description
DEVICE	Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4	To assess the safety and effectiveness of IVL treatment used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries

Timeline

• Start date: 2021-06-15
• Primary completion: 2022-01-30
• Completion: 2023-07-30
• First posted: 2022-06-28
• Last updated: 2022-06-28

Locations

5 sites across 1 country: China