At a glance
ClinicalIndex Comparison RecordN/ACompleted· 328 enrolled
Drug / intervention
OMEGA™ Monorail Coronary Stent Systemdevice
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.
OMEGA: A Prospective, Multicenter Single-Arm Trial to Assess the OMEGA™ Coronary Stent System for the Treatment of a Single De Novo Coronary Artery Lesion
In Brief
A clinical study evaluating OMEGA™ Monorail Coronary Stent System for Atherosclerosis and Coronary Artery Disease. Completed, enrolled 328 participants across 37 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis, Coronary Artery Disease
CountriesBelgium, France, Germany, Latvia, Netherlands, Spain, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartOct 2011
Primary CompletionOct 2013
Study CompletionJan 2014
TodayJul 2026
First PostedAug 18, 2011
Enrollment StartOct 1, 2011
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.9 years ago
Interventions
OMEGA™ Monorail Coronary Stent Systemdevice
All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.