Trials / Completed
CompletedNCT01419171
The OMEGA Clinical Trial
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 328 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OMEGA™ Monorail Coronary Stent System | All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure. |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2013-10-01
- Completion
- 2014-01-01
- First posted
- 2011-08-18
- Last updated
- 2014-09-25
- Results posted
- 2014-08-15
Locations
37 sites across 7 countries: United States, Belgium, France, Germany, Latvia, Netherlands, Spain
Source: ClinicalTrials.gov record NCT01419171. Inclusion in this directory is not an endorsement.