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Lumason® Infusion vs. Bolus Administrations
Sponsor: Bracco Diagnostics, Inc
Summary
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Official title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
106
Start Date
2024-07-10
Completion Date
2026-12-31
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
Lumason
Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min
Locations (6)
Interventional Cardiology Medical Group
West Hills, California, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Oregon Health and Sciences University
Portland, Oregon, United States
University of Texas Medical Branch
Galveston, Texas, United States
Vital Heart and Vein
Humble, Texas, United States