The ULtrasound guided TRAnsfemoral access in COmplex Large bORe trial is an international multicenter RCT and will randomized patients with planned complex large bore PCI to either ultrasound guided or fluoroscopy guided transfemoral access.
The recently published COLOR trial has delivered sound evidence for the safety and efficacy of large bore transradial access in complex PCI, but a significant proportion of patients will still need treatment through transfemoral route, especially in dual arterial access in PCI CTO where biradial access is not always possible. More efforts to reduce access site complications and increase procedural safety in these patients are important. For this reason, the ULTRACOLOR trial has been designed.
The ULTRACOLOR trial aims to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related complications as compared to fluoroscopy-guided femoral access for complex PCI with large-bore access.
The primary endpoint is the occurrence of clinically relevant primary femoral access site related complications during index hospitalization.
The ULTRACOLOR trial is an international, multicenter, prospective, randomized clinical trial designed to enroll 542 patients in 10 centers in the Netherlands, Belgium and Germany.
The first patient was enrolled on 9 June 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 investigator is Alexander Nap, MD, PhD (interventional cardiologist Amsterdam UMC, Amsterdam, the Netherlands).