Start Date
April 30, 2016
Primary Completion Date
May 31, 2018
Study Completion Date
December 31, 2018
COMBO-Stent
The OrbusNeich COMBO Bio-engineered Sirolimus Eluting Stent (COMBO Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable poly-mer containing sirolimus. Covalently attached to the surface of the stent is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets circulatory CD34+ cells (endothelial progenitor cells) thus favoring endothelialization.
Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
Anticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC
Any drug eluting stent oder bare metal sent
Implantation of traditional bare metal stents and/or drug eluting stents (any device approved on the market, implanted according to CE marking and IFU) and medication regimen in accordance with ESC Guidelines
ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran
A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)
MVZ am Kuechwald GmbH, Chemnitz
Elisabeth Krankenhaus, Essen
Universitaetsmedizin Mainz, Mainz
Theresienkrankenhaus und St. Hedwig GmbH, Mannheim
Universitaetsmedizin Mannheim, Mannheim
St. Franziskus, Kliniken Maria Hilf GmbH, Mönchengladbach
Evangelisches Krankenhuas Muehlheim a.d. Ruhr GmbH, Muehlheim An Der Ruhr
Diakonissen-Stiftungs-Krankenhaus, Speyer
Herzklinik Ulm GbR, Ulm
Schwarzwald-Baar-Klinikum, Villingen-Schwenningen
Collaborators (1)
OrbusNeich
INDUSTRY
IHF GmbH - Institut für Herzinfarktforschung
OTHER