Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-04 @ 7:11 AM
Study NCT ID:
NCT06400004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lumason® Infusion vs. Bolus Administrations
Sponsor:
Bracco Diagnostics, Inc
Organization:
Study Overview
Official Title:
A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: