At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 175 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 175 participants across 17 sites in 4 countries.
Detailed Summary
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (CE-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
CountriesCanada, Germany, Italy, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionNov 2017
Study CompletionFeb 2018
TodayJul 2026
First PostedAug 13, 2015
Enrollment StartSep 24, 2015
Primary CompletionNov 7, 2017
Study CompletionFeb 25, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.9 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