Article Text

Protocol
ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial
  1. Thomas A Meijers1,
  2. Alexander Nap2,
  3. Adel Aminian3,
  4. Joseph Dens4,
  5. Koen Teeuwen5,
  6. Jan-Peter van Kuijk6,
  7. Marleen van Wely7,
  8. Thomas Schmitz8,
  9. Yoann Bataille9,
  10. Adriaan O Kraaijeveld10,
  11. Vincent Roolvink1,
  12. Renicus S Hermanides1,
  13. Thijs L Braber1,
  14. Niels van Royen7,
  15. Maarten A H van Leeuwen1
  1. 1Department of Cardiology, Isala Heart Centre, Zwolle, The Netherlands
  2. 2Department of Cardiology, Amsterdam UMC Locatie VUmc, Amsterdam, The Netherlands
  3. 3Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium
  4. 4Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium
  5. 5Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands
  6. 6Department of Cardiology, Sint Antonius Hospital, Nieuwegein, The Netherlands
  7. 7Department of Cardiology, Radboudumc, Nijmegen, The Netherlands
  8. 8Department of Cardiology, Elisabeth-Krankenhaus-Essen GmbH, Essen, Germany
  9. 9Department of Cardiology, Jessa Ziekenhuis vwz, Hasselt, Belgium
  10. 10Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands
  1. Correspondence to Dr Maarten A H van Leeuwen; m.a.h.van.leeuwen{at}isala.nl

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.

  • Coronary intervention
  • Coronary heart disease
  • Ischaemic heart disease
http://creativecommons.org/licenses/by-nc/4.0/

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/.

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Footnotes

  • Twitter @Jo Dens

  • Contributors MvL, AN and TAM substantially contributed to conception and design of the study protocol. TAM, AA, KT, MvW, TS, JD, YB, AOK, J-PvK, TLB, RH, VR and MvL contributed to acquisition of data. TAM and MvL contributed to analysis of data. TAM, AN, MvL and NvR contributed to interpretation of data. TAM, AN, NvR and MvL reviewed the literature, contributed to the design and wrote the draft of the manuscript. TAM, AA, KT, MvW, TS, JD, YB, AOK, J-PvK, TLB, RH, VR, NvR and MvL contributed to refinement of the study protocol and approved the final manuscript.

  • Funding Unrestricted research grant by TOP Medical Consultancy b.v.

  • 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.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.