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. 2022 Dec 1;12(12):e065693.
doi: 10.1136/bmjopen-2022-065693.

ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial

Thomas A Meijers  1 , Alexander Nap  2 , Adel Aminian  3 , Joseph Dens  4 , Koen Teeuwen  5 , Jan-Peter van Kuijk  6 , Marleen van Wely  7 , Thomas Schmitz  8 , Yoann Bataille  9 , Adriaan O Kraaijeveld  10 , Vincent Roolvink  1 , Renicus S Hermanides  1 , Thijs L Braber  1 , Niels van Royen  7 , Maarten A H van Leeuwen  11
Affiliations

ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial

Thomas A Meijers et al. BMJ Open. .

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 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.

Keywords: Coronary heart disease; Coronary intervention; Ischaemic heart disease.

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Conflict of interest statement

Competing interests: 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.

Figures

Figure 1
Figure 1
Study flow chart. Graphic representation of inclusion for the ultrasound guided transfemoral access in complex large bore PCI trial. PCI, percutaneous coronary intervention; STEMI-ST, segment elevation myocardial infarction.
Figure 2
Figure 2
Puncture height classification for femoral artery access. CFA, common femoral artery; EIA, external iliac artery; IEA, inferior epigastric artery; PFA, profunda femoral artery; SFA, superficial femoral artery.
Figure 3
Figure 3
Long axis (left) and short axis (right) view of guidewire entering the common femoral artery at the correct position.
See this image and copyright information in PMC

References

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