At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
PROMUS Element™device
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, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)
In Brief
A Phase 3 clinical trial evaluating PROMUS Element™ for Atherosclerosis and Coronary Artery Disease. Completed, enrolled 100 participants across 17 sites in 4 countries.
Detailed Summary
Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Element™ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis, Coronary Artery Disease
CountriesAustralia, Malaysia, New Zealand, Singapore
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartMar 2009
Primary CompletionSep 2009
Study CompletionAug 2010
TodayJul 2026
First PostedJan 16, 2009
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.5 years ago
Interventions
PROMUS Element™device
Drug eluting coronary stent system