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The OMEGA Clinical Trial
NCT01419171 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01419171
The ClinicalTrials.gov registry entry for NCT01419171 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 328 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01419171 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Ohio, Arkansas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01419171?
The interventions under investigation include: OMEGA™ Monorail Coronary Stent System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01419171?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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