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COMPLETED
NCT05818098
NA

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

Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

189

Start Date

2023-03-29

Completion Date

2023-09-15

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

The Second Affliated Hospital Ha'erbin Medical University

Harbin, Heilongjiang, China