DISCO COMPLEX Trial

  • Research type

    Research Study

  • Full title

    DIStal versus COnventional radial access for COMPLEX large-bore percutaneous coronary intervention: The DISCO COMPLEX randomized trial

  • IRAS ID

    348649

  • Contact name

    Juan Fernando Iglesias

  • Contact email

    juanfernando.iglesias@hug.ch

  • Sponsor organisation

    University of Geneva, Cardiology Department, Interventional Cardiology Unit

  • Clinicaltrials.gov Identifier

    NCT05490238

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    DISCO COMPLEX is a randomized controlled trial initiated by the investigator, with the principal investigator and sponsor being the University Hospitals of Geneva. It is a multicenter and international study that will include a total of 708 patients from Switzerland, Belgium, Italy, UK, and Germany. The study aims to compare the conventional radial vascular access route with an alternative access route, called the distal radial approach, located at the anatomical snuffbox or the back of the hand, in patients indicated for a so-called complex angioplasty. This includes procedures like left main coronary artery angioplasty, chronic total occlusion, highly calcified lesions, or coronary bifurcation lesions requiring a large vascular access (7 French).

    DISCO COMPLEX will be the first randomized study in interventional cardiology aimed at demonstrating the superiority of the distal radial approach compared to the conventional radial approach in terms of the rate of radial artery occlusion. If the study hypothesis is confirmed, preserving radial artery patency through the use of the distal radial approach would allow patients to retain their radial artery as a potential conduit for future procedures, such as repeat interventions, coronary artery bypass grafting, or an arteriovenous fistula in case hemodialysis is needed.

    Additionally, the study will include a pre-specified sub-study within the protocol, DISCOPHILE COMPLEX, which will assess the function of the hand used for the complex angioplasty access one year later. This assessment will be conducted using validated questionnaires as well as motor and sensory tests to detect any sequelae in the patient with each of these vascular access routes. Our hypothesis is that the distal radial approach is not inferior to the conventional radial approach in terms of hand function after one year.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    25/LO/0023

  • Date of REC Opinion

    11 Apr 2025

  • REC opinion

    Further Information Favourable Opinion