Coronary Artery Disease
Conditions
Brief 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.
Interventions
DEVICEPercutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Stenting
DEVICEPercutaneous Coronary Intervention (Orsiro DES)
stenting
Sponsors
Biotronik AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Subject has provided a written informed consent * Single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries * The target lesion length is ≤ 26 mm * The target reference vessel diameter is ≥ 2.25 mm and ≤ 4.0 mm Main
Exclusion criteria
* Evidence of myocardial infarction within 72 hours prior to index procedure * Unprotected left main coronary artery disease (stenosis \>50%) * Three-vessel coronary artery disease at time of procedure Thrombus in target vessel * Target lesion involves a side branch \> 2.0 mm in diameter * Heavily calcified lesion * Target lesion is located in or supplied by an arterial or venous bypass graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late Lumen Loss | 9 months post index procedure |
Countries
Austria, France, Germany, Hungary, Latvia, Netherlands, Spain, Switzerland
Outcome results
None listed