Intravascular ultrasound guidance for complex high-risk indicated procedures: The IVUS CHIP trial study design
Roberto Diletti1, Joost Daemen1, Benjamin Faurie2
1Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands.
Background:
Intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention (PCI) has been associated with a reduction in clinical events. Whereas most evidence is generated in Asian-Pacific populations, its global adoption remains low.
Methods:
The IVUS complex high-risk indicated procedures (CHIP) trial is a multicenter, international, event-driven, randomized superiority trial comparing IVUS-guided PCI with angio-guided PCI during complex high-risk indicated procedures. The primary endpoint is target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target vessel revascularization. The IVUS CHIP trial utilizes an event-driven approach. The outcomes for the primary endpoint are first reported when at least 169 patients with a primary endpoint have been confirmed. A total of 2020 patients will be enrolled in 37 European sites.
Conclusions:
The aim of the IVUS CHIP trial is to assess the superiority of an IVUS-guided approach vs an angio-guided approach in patients undergoing complex high-risk indicated procedures in terms of the study primary endpoint of target vessel failure.
Trial Registration:
The IVUS CHIP trial is registered at ClinicalTrial.gov and assigned the identifier NCT04854070.
Related Concept Videos
01:26Cardiac Catheterization IV: Nursing Management
01:21Cardiac Catheterization II: Right Heart Catheterization