Trials / Unknown
UnknownNCT01356888
Study of the Orsiro Drug Eluting Stent System
BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 452 (actual)
- Sponsor
- Biotronik AG · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) | Stenting |
| DEVICE | Percutaneous Coronary Intervention (Orsiro DES) | stenting |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2013-07-01
- Completion
- 2018-12-01
- First posted
- 2011-05-20
- Last updated
- 2018-05-31
Locations
24 sites across 8 countries: Austria, France, Germany, Hungary, Latvia, Netherlands, Spain, Switzerland
Source: ClinicalTrials.gov record NCT01356888. Inclusion in this directory is not an endorsement.