September 2nd, 2021
ECRI announces the IVUS CHIP multicenter clinical trial to determine the effectiveness of IVUS-guided revascularization compared with angio-guided revascularization in patients undergoing complex high-risk indicated coronary procedures
Rotterdam, the Netherlands – the European Cardiovascular Research Institute (ECRI) announced today a multicenter European clinical trial which plans to investigate the use of intravascular ultrasound (IVUS) to guide coronary revascularization in patients undergoing complex high-risk indicated (CHIP) procedures.
IVUS has been reported to improve outcomes after percutaneous coronary interventions (PCI), and is used for coronary lesion severity assessment, lesion preparation guidance, stent implantation guidance and optimization. However, large prospective trials identifying the specific subset of patients who benefit the most from an IVUS guided revascularization are lacking and the adoption of this imaging modality remains low worldwide with the exception of Asian countries.
European guidelines report that intravascular imaging should be considered in selected cases to optimize stent implantation, in particular in left main (LM) lesions and in-stent restenosis (ISR). American guidelines define as reasonable the use of IVUS in equivocal LM disease or in case of ISR but do not support routine IVUS use during PCI.
Data derived from non-randomized studies and meta-analyses suggests a high impact of IVUS guidance on clinical event reduction, in complex lesions and more specifically in chronic total occlusions, ostial or heavily calcified lesions, in-stent restenosis, long lesions, true bifurcations, and left main stenosis. Based on these observations the recent consensus document on clinical use of intravascular coronary imaging highlighted the relevance of IVUS mainly in complex scenarios, which are observed in almost one third of patients undergoing PCI.
The IVUS CHIP trial is a randomized controlled, multicenter, international, event-driven, trial. A total of 2020 participants will be randomized in a 1:1 fashion to IVUS-guided PCI versus angio-guided PCI. Patients will be consented prior to the PCI procedure and then followed up to 2 years after randomization. This outcome trial plans to enroll participants in 40 sites and 7 European countries (The Netherlands, United Kingdom, France, Spain, Italy, Belgium and Germany), and report its primary endpoint according to the statistical principles of the event-driven design. The OptiCross High Definition IVUS catheter will be used in the trial (Boston Scientific, Marlborough, MA, United States).
The study is overseen by a panel of renowned experts in cardiovascular research, including Dr. Roberto Diletti, Principal Investigator of the IVUS CHIP trial (Erasmus Medical Center, Rotterdam, the Netherlands), Prof. Nicolas Van Mieghem, Chairman of the IVUS CHIP trial (Erasmus Medical Center, Rotterdam, the Netherlands), Dr. Joost Daemen, Co-Principal Investigator (Erasmus Medical Center, Rotterdam, the Netherlands), Prof. Adrian Banning (John Radcliffe Hospital, Oxford, United Kingdom), Prof. Jan Tijssen (ECRI, Rotterdam, the Netherlands) and Dr. Ernest Spitzer (ECRI, Rotterdam, the Netherlands), as sponsor representative.
The trial is sponsored by ECRI and funded by a research grant from Boston Scientific International S.A. (Voisins-le-Bretonneux, France). Cardialysis (Rotterdam, The Netherlands), an expert cardiovascular research organization, is responsible for trial services including trial management, regulatory submissions, monitoring, data management and eCRF development, safety monitoring and reporting, endpoint adjudication, statistics, as well as Core Laboratory activities.
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