Garin, Etienne
Pinaquy, Jean-Baptiste
Bailly, Clement
Sengel, Christian
Mariano-Goulart, Denis
Edeline, Julien
Blanc, Jean-Frederic
Bouvier, Antoine
Tordo, Jeremie
Rode, Agnes
Becker, Stéphanie
Sefrioui, David
de Baere, Thierry
Somma, Claude
Mastier, Charles
Goupil, Jean
Chevallier, Patrick
Regnault, Helene
Vibert, Eric
Manfredi, Sylvain
Vicaut, Eric
Patel, Binal
Boucher, Eveline
Guiu, Boris http://orcid.org/0000-0003-1277-3054
,
Funding for this research was provided by:
Boston Scientific Corporation
Article History
Received: 11 August 2021
Accepted: 29 October 2021
First Online: 18 November 2021
Declarations
:
: E.G.: Received fees and a grant from BTG Ltd./Boston Scientific Corporation. J.P.: Nothing to disclose. C.B.: Nothing to disclose. C.S.: Nothing to disclose. D.M-G.: Nothing to disclose. J.E.: Received fees and support for research from Boston Scientific; consultant for Roche, AstraZeneca, MSD, BMS, Eisai, Bayer, and Ipsen. J-F.B: Consultant for Bayer, Astra-Zeneca, IPSEN, ESAI, Roche, and BMS. A.B.: Nothing to disclose. J.T.: Nothing to disclose. A.R: Nothing to disclose. S.B.: Nothing to disclose. D.S.: Nothing to disclose. T. de B.: Consultant for Boston Scientific Corporation, Guerbet, GE-Healthcare, HD Technologies, Terumo, Astra-Zeneca, and Eisai; speaker for Boston Scientific Corporation, Guerbet, GE-Healthcare, HD Technologies, and Terumo. C. S-D: Nothing to disclose. C.M.: Nothing to disclose. J.G.: Nothing to disclose. P.C.: Nothing to disclose. H.R.: Consultant for Boston Scientific Corporation. E.V.: Received fees for methodological consulting from Biocompatibles UK Ltd. S.M.: Nothing to disclose. E.V.: Receives fees from Bayer, BMS, Johnson & Johnson, and Boston Scientific Corporation; serves as consultant for Nanobiotix; academic collaboration with EchoSens, Fluoptics, and IntraSence. B.P.: Employee of Biocompatibles/Boston Scientific Corporation. E.B.: Employee of Biocompatibles/Boston Scientific Corporation. B.G.: Consultant for Boston Scientific, Quantum Surgical, Terumo. Received research grant from Roche, Guerbet.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was classified in France as Recherche Impliquant la Personne Humaine de Catégorie 3 (RIHP 3) by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) due to its observational, non-interventional design. The protocol was approved by a randomly assigned to one of the 39 Independent Ethics Committees in France prior to the study’s initiation (assigned to French Ethics Committee « Ile de France VII»); assignments are made by the French National Commission for Research Involving Human Persons (CNRIPH).
: Patients will receive a Patient Information Sheet (PIS), which they will be able to review prior to treatment and about which patients will be given the opportunity to ask questions of the investigator or delegate. As detailed by the General Data Protection Regulation (GDPR) and requested by the ethics committee, this PIS will inform the patient about the purpose and aim of the registry and how their personal medical data will be used. After reviewing this sheet, clinicians will document whether the patient expresses verbal non-opposition to data collection in the patient’s record (“non-opposition to data collection”).
: Consent for publication was obtained for every individual person’s data included in the study.