Document is current
Any future updates will be listed below
-
Authors
Hommels, T. M. http://orcid.org/0000-0002-8527-6254
Hermanides, R. S.
Berta, B.
Fabris, E.
De Luca, G.
Ploumen, E. H.
von Birgelen, C.
Kedhi, E.
-
Funding
Funding for this research was provided by:
Department of Cardiology, Isala Hospital, Zwolle
- License Information
-
More Information
Article History
Received: 28 June 2020
Accepted: 12 September 2020
First Online: 2 October 2020
Ethics approval and consent to participate
: The ABSORB DM Benelux Study (NTR5447) was performed in concurrence with the Declaration of Helsinki and was registered at the Netherlands Trial Register (NTR) acknowledged by the World Health Organization (WHO) and International Committee of Medical Journal Editors (ICMJE). The TWENTE (NTR1256/NCT01066650) and DUTCH PEERS (NTR2413/NCT01331707) trials were both conducted in concurrence with the Declaration of Helsinki and were registered at the NTR as well as at ClinicalTrials.gov. An approval for ethical committees was sought in all participating centers and countries. The clinical investigations did not test any non-approved device. The ABSORB BVS and the ABSORB GT1 are CE marked products and were used widely in daily clinical practice all over the world from 2009 to 2017. The Xience V EES is widely utilized since 2007 and the Promus Element EES since 2010. These clinical trials do not involve a medicinal product and are therefore not subject to The European Clinical Trials Directive (2001/20/EC).
: Not applicable.
: E.H. Ploumen and C. von Birgelen indicated that the research department of Thoraxcentrum Twente has received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific and Medtronic. The other authors declare that they have no competing interests.
