The ULTRA-CTO study is a prospective multicentre investigator-initiated trial designed to enroll 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery and who have at least one intermediate (angiographically 30-90%) stenosis in a non-CTO vessel or major side branch of the CTO vessel with a diameter of at least 2 mm.
The ULTRA-CTO trial will investigate the use of RFR to evaluate suboptimal stent result as assessed by optical coherence tomography (OCT). The main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients. This study will provide novel insights to optimize procedural results of PCI CTO and it will improve our understanding of the dynamic physiology in the macro and microcirculation.
200 patients will be enrolled in 2 centers in the Netherlands. The first patient was enrolled on 31 August 2021 at Isala Heart Center Zwolle, the Netherlands.
The principal and coordinating investigator is Maarten van Leeuwen, MD, PhD (interventional cardiologist Isala, Zwolle, The Netherlands). The co-principal investigators are Miguel Lemmert, MD, PhD (interventional cardiologist Isala, Zwolle, The Netherlands) and Sander IJsselmuiden, MD, PhD (interventional cardiologist Amphia hospital, Breda, the Netherlands).