ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial. Issue 12 (1st December 2022)

• Record Type: Journal Article
• Authors: Meijers, Thomas A; Nap, Alexander; Aminian, Adel; Dens, Joseph; Teeuwen, Koen; van Kuijk, Jan-Peter; van Wely, Marleen; Schmitz, Thomas; Bataille, Yoann; Kraaijeveld, Adriaan O; Roolvink, Vincent; Hermanides, Renicus S; Braber, Thijs L; van Royen, Niels; van Leeuwen, Maarten A H
• Is Part Of: BMJ open. Volume 12:Issue 12(2022)
• Publication Date: 2022-12-01
• Subjects: Coronary intervention -- Coronary heart disease -- Ischaemic heart disease; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-065693
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date. Methods and analysis: A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups. Ethics and dissemination: Ethical approval for the study was granted by the local Ethics Committee ('Medisch Ethische Toetsing Commissie Isala Zwolle') for all Dutch sites, 'Comité Medische Ethiek Ziekenhuis Oost-Limburg' for Hospital Oost-Limburg, 'Comité d'éthique CHU-Charleroi—ISPPC' for Centre Hospilatier Universitaire de Charleroi and 'Ethik Kommission de Ärztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ul trasound guided tra nsfemoral access in co mplex l arge b or e PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752 . Registration details: ClinicalTrials.gov identifier: NCT03846752 .