NCT05818098

Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)

A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Intravascular Lithotripsy System in Patients With Coronary Artery Calcification

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.

Detailed description

This trial is a prospective and multicenter clinical trial. 189 subjects are expected to be recruited in 20 research centers in China. 1. All subjects with coronary calcified lesions participating in this clinical study must have only one lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.00 mm but ≤ 4.00 mm. 2. All subjects receive clinical follow-up during hospitalization, 30 days and 6 months after surgery.

Conditions

• Coronary Artery Calcification

Interventions

Type	Name	Description
DEVICE	Intravascular Lithotripsy System of Shanghai MicroPort Rhythm	The Intravascular Lithotripsy System is a single-use, sterile, disposable balloon angioplasty catheter that contains a series of unfocused, electrohydraulic lithotripsy emitters, which convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium within vascular plaque.

Timeline

• Start date: 2023-03-29
• Primary completion: 2023-09-01
• Completion: 2024-03-01
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: China