This trial is active, not recruiting.

Condition coronary artery disease
Treatments percutaneous coronary intervention (abbott laboratories - xience prime des), percutaneous coronary intervention (orsiro des)
Phase phase 4
Sponsor Biotronik AG
Start date May 2011
End date July 2013
Trial size 440 participants
Trial identifier NCT01356888, C1004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
percutaneous coronary intervention (abbott laboratories - xience prime des)
percutaneous coronary intervention (orsiro des)

Primary Outcomes

Late Lumen Loss
time frame: 9 months post index procedure

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II
Principal investigator Stephan Windecker, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Biotronik AG.