TY - JOUR
T1 - ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI
T2 - study protocol of the UltraCOLOR trial
AU - Meijers, Thomas A.
AU - Nap, Alexander
AU - Aminian, Adel
AU - Dens, Joseph
AU - Teeuwen, Koen
AU - van Kuijk, Jan-Peter
AU - van Wely, Marleen
AU - Schmitz, Thomas
AU - Bataille, Yoann
AU - Kraaijeveld, Adriaan O.
AU - Roolvink, Vincent
AU - Hermanides, Renicus S.
AU - Braber, Thijs L.
AU - van Royen, Niels
AU - van Leeuwen, Maarten A. H.
N1 - Funding Information: Unrestricted research grant by TOP Medical Consultancy b.v. Funding Information: Maarten van Leeuwen: speakers/consulting services honoraria from Terumo, Daiichi-Sankyo and Abbott. Research grants from AstraZeneca, Top Sector Life Sciences & Health, Terumo, Top Medical B.V and Abbott. Adriaan Kraaijeveld: research grants from Xenios AG. Lecture fees from Abiomed, Novartis and Inari. Consultancy fees from Dekra and Boston Scientific. All other authors have no competing interests to declare. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/12/1
Y1 - 2022/12/1
N2 - 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 Arztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752. Registration details ClinicalTrials.gov identifier: NCT03846752.
AB - 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 Arztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752. Registration details ClinicalTrials.gov identifier: NCT03846752.
KW - Coronary heart disease
KW - Coronary intervention
KW - Ischaemic heart disease
UR - http://www.scopus.com/inward/record.url?scp=85143186404&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2022-065693
DO - https://doi.org/10.1136/bmjopen-2022-065693
M3 - Article
C2 - 36456007
SN - 2044-6055
VL - 12
SP - e065693
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e065693
ER -