At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 174 enrolled
Drug / intervention
Lumasondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Multicenter Phase III Clinical Evaluation of the Safety and Efficacy of Lumason™/SonoVue® in Subjects Undergoing Pharmacologic Stress Echocardiography With Dobutamine for the Diagnosis of Coronary Artery Disease
In Brief
A Phase 3 clinical trial evaluating Lumason for Coronary Artery Disease. Completed, enrolled 174 participants across 13 sites in 4 countries.
Detailed Summary
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesBelgium, Canada, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionJun 2017
Study CompletionFeb 2018
TodayJul 2026
First PostedSep 17, 2015
Enrollment StartOct 12, 2015
Primary CompletionJun 22, 2017
Study CompletionFeb 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.8 years ago
Interventions
Lumasondrug
Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography