The COMBINE trial, published in the European Heart Journal and recently presented as a Late Breaking Trial during TCT Connect 2020, shows that patients with a OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia.
The Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO) is a declaration of feasibility of a clinical study in a (research) centre in the Netherlands. It’s a new document that replaces the current Research Declaration for studies subject to the Medical Research Involving Human Subjects Act (WMO) in the Netherlands. It is part of the new procedure Local Feasibility.
On 26th May 2021, Europe implemented stricter rules for medical devices (MDR) aiming to give patients more clarity and enabling them to make a better and well-informed choice. The new directives have consequences for manufacturers, importers, distributors and care providers.
Dr. A.F. Hoogerwaard defended her PhD thesis titled ‘Renal Sympathetic Denervation: ‘From acute renal nerve stimulation induced hemodynamic changes to long-term clinical perspectives’ on 17 February 2021 at the Groningen University.