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NCT06400004PHASE3Recruiting

Lumason® Infusion vs. Bolus Administrations

Bracco Diagnostics, Inc

Start Date

7/10/2024

Completion Date

12/31/2026

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).

Detailed Description

This is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Are at least 18-years old; * Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram; * Provide their written informed consent and are willing to comply with protocol requirements. Exclusion Criteria: * Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association); * Patient has uncontrolled angina (i.e., uncontrolled on medication); * Patient had a recent myocardial infarction (within the last 3 days and not stabilized); * Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct; * Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct; * Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration; * Has any known allergy to one or more of the ingredients of the investigational product; * Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses; * Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study; * Is determined by the Investigator that the patient is clinically unsuitable for the study.

Interventions

DRUG

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

DRUG

Lumason

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Conditions

Heart Diseases

Locations

Interventional Cardiology Medical Group

West Hills, California 91307

United States

Piedmont Heart Institute

Atlanta, Georgia 30309

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Oregon Health and Sciences University

Portland, Oregon 97239

United States

University of Texas Medical Branch

Galveston, Texas 77555

United States

Vital Heart and Vein

Humble, Texas 77338

United States