Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/39655
Title: | ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial | Authors: | 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. |
Issue Date: | 2022 | Publisher: | BMJ PUBLISHING GROUP | Source: | BMJ Open, 12 (12) (Art N° e065693) | 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 1month 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, 'Comite Medische Ethiek Ziekenhuis Oost-Limburg' for Hospital Oost-Limburg, 'Comite d'ethique 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 detailsClinicalTrials.gov identifier: NCT03846752. | Notes: | van Leeuwen, MAH (corresponding author), Isala Heart Ctr, Dept Cardiol, Zwolle, Netherlands. m.a.h.van.leeuwen@isala.nl |
Keywords: | Coronary intervention;Coronary heart disease;Ischaemic heart disease | Document URI: | http://hdl.handle.net/1942/39655 | ISSN: | 2044-6055 | e-ISSN: | 2044-6055 | DOI: | 10.1136/bmjopen-2022-065693 | ISI #: | 000935444100014 | Rights: | 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. Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
e065693.full.pdf | Published version | 863.25 kB | Adobe PDF | View/Open |
savedrecs (1).ciw | 162.1 kB | Unknown | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.