1. ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial
- Author
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Thomas A Meijers, Alexander Nap, Adel Aminian, Joseph Dens, Koen Teeuwen, Jan-Peter van Kuijk, Marleen van Wely, Thomas Schmitz, Yoann Bataille, Adriaan O Kraaijeveld, Vincent Roolvink, Renicus S Hermanides, Thijs L Braber, Niels van Royen, Maarten A H van Leeuwen, Meijers, Thomas A., Nap, Alexander, Aminian, Adel, DENS, Jo, 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., Cardiology, and ACS - Atherosclerosis & ischemic syndromes
- Subjects
Coronary heart disease ,Femoral Artery ,Ischaemic heart disease ,Percutaneous Coronary Intervention ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,Vascular damage Radboud Institute for Molecular Life Sciences [Radboudumc 16] ,Coronary intervention ,Humans ,General Medicine ,Punctures ,Vascular Diseases ,Ultrasonography, Interventional - Abstract
IntroductionAlthough 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 analysisA 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 disseminationEthical 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. Theultrasound guidedtransfemoral access incomplexlarge bore PCI trial has been administered in the ClinicalTrials.gov database, reference number:NCT03846752.Registration detailsClinicalTrials.gov identifier:NCT03846752.
- Published
- 2022
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