Dake, Michael D.
Ansel, Gary M.
Bosiers, Marc
Holden, Andrew
Iida, Osamu
Jaff, Michael R.
Lottes, Aaron E.
O’Leary, Erin E.
Saunders, Alan T.
Schermerhorn, Marc
Yokoi, Hiroyoshi
Zeller, Thomas
Funding for this research was provided by:
Cook Medical (1)
Article History
Received: 24 July 2019
Accepted: 21 August 2019
First Online: 9 September 2019
Compliance with Ethical Standards
:
: MDD and GMA are paid consultants for Cook Medical. AH is a Medical Advisory Board member for Boston Scientific Corp., Gore & Associates and Medtronic, and is a Clinical Investigator for Cook Medical, Shockwave, Intact Vascular, Endologix, Philips. MRJ is a non-compensated advisor for Abbott Vascular, Boston Scientific, and a compensated advisor for Biotronik, Medtronic, Philips/Volcano, Micell, Vactronix, Sanofi; Equity Investor: Embolitech, Gemini, PQ Bypass, and Vascular Therapies. AEL, EEO’L, and ATS are paid employees of Cook Medical. MS is a paid consultant for Abbott, Cook, Endologix, Medtronic, Philips, and Silk Road. HY has received honoraria from Boston Scientific Corp, Cook Medical, and Terumo. TZ has received honoraria from Abbott Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave; consulted for Boston Scientific Corp., Gore & Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, Vesper Medical; received (institution) research, clinical trial, or drug study funds from 480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun, and has common stock in QT Medical. MB and OI report no relevant conflicts to disclose.
: 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 Declaration of Helsinki and its later amendments or comparable ethical standards.
: For the Zilver PTX RCT, informed consent was obtained from all individual participants included in the study. For the Japan DES PMS and Japan BMS PMS studies, informed consent processes were determined by each institution’s ethical committee policy to specify whether informed consent was necessary or outcome data could be abstracted while protecting patients’ rights without requiring individual patient consent.