Lumason® Infusion vs. Bolus Administrations

Recruiting Phase 3 Interventional Study
Heart Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
106 (estimated)
Sponsor
Bracco Diagnostics, Inc · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
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…
Contacts

Rushil Sankpal

609-514-2267

rushil.sankpal@diag.bracco.com

CONTACT