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Intravascular Balloon Lithotripsy in Left Main Stem Percutaneous Coronary Intervention

NCT04319666 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-24

No results posted yet for this study

Summary

The IVL Left Main study is a prospective non-randomised pilot study to investigate the mechanical and procedural outcomes and safety of distal left main stenting with coronary lithotripsy in addition to standard techniques in patients with calcific left main disease and a clinical indication for revascularisation.

Conditions

  • Coronary Artery Calcification
  • Left Main Coronary Artery Disease

Interventions

DEVICE

Left main stenting with intravascular lithotripsy

Intravascular lithotripsy (IVL) will be used to modify coronary artery calcification prior to stent implantation in left main coronary disease. Intravascular ultrasound (IVUS) will be used pre and post IVL and post stenting.

Sponsors & Collaborators

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • St George's, University of London

    lead OTHER

Principal Investigators

  • James Spratt · St George's University Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-03-01
Completion
2022-03-01

Countries

  • United Kingdom

Study Locations

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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 NCT04319666 on ClinicalTrials.gov