Trials / Completed
CompletedNCT01148329
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,010 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coronary stenting | The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm. |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2012-06-01
- Completion
- 2016-12-01
- First posted
- 2010-06-22
- Last updated
- 2017-02-02
Locations
40 sites across 11 countries: Austria, Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01148329. Inclusion in this directory is not an endorsement.