🏛️ Verified NIH Record • Updated 2026-03-04
Lumason® Infusion vs. Bolus Administrations (NCT06400004)
🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Bracco Diagnostics, Inc
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (11 items).
Location: Interventional Cardiology Medical Group — West Hills, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- Interventional Cardiology Medical Group — West Hills, California
- Piedmont Heart Institute — Atlanta, Georgia
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Oregon Health and Sciences University — Portland, Oregon
- University of Texas Medical Branch — Galveston, Texas
- Vital Heart and Vein — Humble, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.