Moreno-Sánchez, T. http://orcid.org/0000-0003-1207-4616
Moreno-Ramírez, M.
Machancoses, F. H.
Pardo-Moreno, P.
Navarro-Vergara, P. F.
García-Revillo, J.
Funding for this research was provided by:
Biotronik (Ref.2015 CEM BIOTRONIK S.A./FABIS 01)
Article History
Received: 23 June 2019
Accepted: 31 October 2019
First Online: 13 November 2019
Compliance with Ethical Standards
:
: The first author has received inscription to two courses: by Abbot (CLIC 2019) and by COOK (venous interventional course in 2018). The second author has received a grant by Bard to attend CIRSE 2018. The fourth author has received a speaker honorarium from Penumbra and from Boston Scientific in the last year
: The trial took place in accordance with recommendations for clinical trials and product assessment in the research phase in the humans, which appears in The Declaration of Helsinki and revised at successive world assemblies (WMA, 2013) and current Spanish legislation on clinical trials (RD 223/2004). ICH-GCP (CPMP/ICH/135/95) rules were adhered to the CEIC (Ethical Committees) of the four hospitals, and the Regional Institute for Health and Clinical Research in Andalusia, Spain (RIHCRA), reviewed and approved the protocol and the signed consent form before recruiting began. Before carrying out any specific procedure in the protocol, the participant signed and dated the informed consent form approved by the CEIC. Monitoring and promotion were carried out by the RIHCRA as well as the coordination of the four centers. Consent for publication was obtained for every individual person’s data included in the study.