BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
585
Target Vessel Failure
Time frame: 12 months post index procedure
Rate of clinically-driven target lesion revascularization (TLR)
Time frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Rate of clinically-driven target vessel revascularization (TVR)
Time frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
Rate of target lesion failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass graft (CABG), any clinically-driven TLR
Time frame: 1-month, 6-month, 12-month, 2-year, 3-year, 4-year and 5-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fiona Stanley Hospital
Murdoch, Australia
Prince of Wales Hospital Sydney
Sydney, Australia
Gasthuisberg Leuven
Leuven, Belgium
AZ Delta, H. Hart Roeselare
Roeselare, Belgium
Roskilde Sygehus Nord
Roskilde, Denmark
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Herz- und Diabeteszentrum NRW - Kardiologische Klinik
Bad Oeynhausen, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Charite Campus Mitte - Med. klinik für Kardiologie
Berlin, Germany
Universitätsklinik Bonn
Bonn, Germany
...and 35 more locations