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

NCT05818098 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

  • Coronary Artery Calcification

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.

Sponsors & Collaborators

  • Shanghai MicroPort Rhythm MedTech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Bo Yu, M.D. · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2023-09-30
Completion
2024-03-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818098 on ClinicalTrials.gov