Otto, Sylvia
Díaz, Victor Alfonso Jiménez
Weilenmann, Daniel
Cuculi, Florim
Nuruddin, Amin Ariff
Leibundgut, Gregor
Alfonso, Fernando
Wan Ahmad, Wan Azman
Pyxaras, Stylianos
Rittger, Harald
Steen, Philip
Gaede, Luise
Schulze, Christian
Wöhrle, Jochen
Rosenberg, Mark
Waliszewski, Matthias W.
Funding for this research was provided by:
B.Braun Melsungen (AAG-O-H-1913)
Friedrich-Schiller-Universität Jena
Friedrich-Schiller-Universität Jena
Article History
Received: 6 January 2023
Accepted: 15 March 2023
First Online: 31 March 2023
Declarations
:
: ‘Ethics approval was obtained from the ethics committee of University of Jena (registration no. 2020-1909-MPG § 23b), followed by all relevant ethics approvals including the responsible ethics committee of the German state. In addition, the national ethics votes were obtained in Switzerland (SwissMedic project ID: 2021 − 0137), Malaysia (IJNREC/531/2021, MREC ID NO: 202185 − 10457) and Spain (CEIm-G: Código de Registro: 2020/643, Hospital de la Princesa Madrid: Nº de Registro: 4439). The study will be conducted in accordance with the latest version of the Declaration of Helsinki and the prerequisite ethics votes as provided in this publication. All patients will provide written informed consent prior to participation in this trial. Special focus was paid to comply with the General Data Protection Regulation in each participating vascular center.
: Not applicable.
: All patient recruiting participants receive remuneration through accounts registered in the name of the vascular centers according to the number of recruited patients. SO is a consultant for the sponsor. PS and MWW are full-time employees of B.Braun Melsungen AG. All other authors have no competing interests.