Albrecht, Thomas
Waliszewski, Matthias
Roca, Catherine
Redlich, Ulf
Tautenhahn, Jörg
Pech, Maciej
Halloul, Zuhir
Gögebakan, Özlem
Meyer, Dirk-Roelfs
Gemeinhardt, Ines
Zeller, Thomas
Müller-Hülsbeck, Stefan
Ott, Ilka
Tepe, Gunnar
Clinical trials referenced in this document:
Documents that mention this clinical trial
Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound?
https://doi.org/10.1007/s00270-018-1940-1
Article History
Received: 27 January 2018
Accepted: 17 March 2018
First Online: 27 March 2018
Compliance with Ethical Standards
:
: TA and GT have received lecturer honoraria and research grants from B.Braun to conduct this trial. MW is a full-time employee in the Medical Scientific Affairs department of B.Braun Melsungen AG, Vascular Systems, Berlin/Germany. SMH received lecturer honoraria and travel grants from Terumo and Boston Scientific. TZ received honoraria from Abbott Vascular, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, Shockwave, Biotronik, QT Medical and consulted for Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, B.Braun.
: The study was approved by the Federal Institute for Drugs and Medical Devices (Ref. 95.05-5660-8211), by the Federal Agency for Radiation Protection (Ref. Z5-22462/2) and by all relevant ethics committees of participating centers. Patients gave written informed consent prior to inclusion. An independent critical event committee was installed to adjudicate event rates. Blinded quantitative angiographic analysis was conducted by an independent core laboratory. This trial was registered with the US National Institutes of Health (clinicaltrials.gov NCT01970579) prior to recruitment. This trial was conducted in accordance with the updated Declaration of Helsinki and other relevant guidance.
: Informed consent was obtained from all individual participants included in the study.