Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01419171 · ClinicalTrials.gov registry record · NA
The OMEGA Clinical Trial
A NA study of Coronary Artery Disease and Atherosclerosis, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 328
- Enrollment target
- 20
- Study locations
NCT01419171: Completed NA study of Coronary Artery Disease and Atherosclerosis, sponsored by Boston Scientific Corporation.
NCT01419171 is a NA study of Coronary Artery Disease and Atherosclerosis that has completed, run by Boston Scientific Corporation. The registered enrollment target is 328 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01419171, a NA study of Coronary Artery Disease and Atherosclerosis, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 328 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Conditions Studied
Interventions
- DEVICE OMEGA™ Monorail Coronary Stent System
Study Locations (20)
Ohio
- The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital - Cincinnati
- Ohio State University Medical Center - Columbus
- The Toledo Hospital - Toledo
- Mercy St. Vincent Medical Center - Toledo
Arkansas
- National Park Medical Center - Hot Springs
- Arkansas Heart Hospital - Little Rock
Florida
- Florida Hospital - Orlando
- Sarasota Memorial Hospital - Sarasota
Minnesota
- St. Mary's Duluth Clinic Regional Heart Center - Duluth
- Regions Hospital - Saint Paul
California
- Loma Linda University Medical Center - Loma Linda
Illinois
- Southern Illinois University-Memorial Medical Center - Springfield
Indiana
- St. Vincent's Hospital - Indianapolis
Kentucky
- St. Joseph Hospital - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT01419171 record still lists
NCT01419171 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which OMEGA™ Monorail Coronary Stent System is the first listed.
NCT01419171 names 20 study sites across 14 states, led by Ohio, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT01419171 about?
NCT01419171 is a clinical study titled "The OMEGA Clinical Trial". 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.
What is the current status of trial NCT01419171?
This trial is currently completed. It is a NA study. The enrollment target is 328 participants. The study started on 2011-10. Estimated completion is 2014-01.
What conditions does trial NCT01419171 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Atherosclerosis.
What interventions are being tested in trial NCT01419171?
The interventions under investigation include: OMEGA™ Monorail Coronary Stent System (DEVICE).
Who is sponsoring clinical trial NCT01419171?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419171 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01419171's enrollment target sits among peer trials
328 100th of 219 higher than 120 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
RECRUITING · NA
-
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
RECRUITING · NA
-
PET/CT* vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease [*PET: Positron Emission Tomography; CT: Computed Tomography]
RECRUITING · NA
-
Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Change in Cardiovascular Health
RECRUITING · NA
-
Impact of Disclosing Coronary Artery Disease Polygenic Risk Score on Cardiovascular Health
RECRUITING · NA
-
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05156983 · 328 participants · Phase 3
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
- NCT05380401 · 328 participants · NA
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
- NCT05548413 · 328 participants · NA
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
- NCT06393725 · 328 participants · NA
Synchronous vs Asynchronous Remotely Delivered Lifestyle Interventions
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia