Intravascular ultrasound guidance for complex high-risk indicated procedures in underrepresented patient populations registry: Rationale and study design of the prospective observational IVUS CHIP UPP registry

• Published in: Cardiovascular revascularization medicine
• Main Authors: Spitzer, Ernest, Paredes, Ximena S., Abbott, J. Dawn, Batchelor, Wayne B., Daemen, Joost, Tijssen, Jan G.P., Kandzari, David E.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 21.06.2025
• Subjects: Cardiovascular; Complex high-risk indicated procedures; Intravascular ultrasound; CEC; DCB; CI; PoCE; ISR; IVUS; CTOs; Intravascular ultrasound; DoCE; ICF; ICH; Complex high-risk indicated procedures; CHIP; DES; ECRI; PCI; Percutaneous coronary intervention; Drug coated balloon; Drug eluting stent; in-stent restenosis; Patient-oriented Composite Endpoint; Chronic total occlusions; Complex High-risk Indicated Procedures; Confidence interval; clinical events committee; European Cardiovascular Research Institute; informed consent form; international conference on Harmonization; Device-oriented Composite Endpoint
• ISSN: 1553-8389; 1878-0938; 1878-0938
• DOI: 10.1016/j.carrev.2025.06.027

Intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) of complex coronary lesions is currently recommended by international guidelines. Complex coronary anatomy is observed in up to one third of the patients undergoing coronary interventions and is associated with worse clinical outcomes. Data on lesion characteristics and outcomes are scarce in census-defined minority groups. The Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures in Underrepresented Patient Populations (UPP) Registry is a prospective, observational, multicenter, single-arm study describing the safety and efficacy of IVUS-guided PCI in approximately 1010 subjects who self-identify within a demographic minority and undergo complex high-risk procedures. Criteria for optimal stenting include final minimal stent area (MSA) >5 mm2 or MSA >90 % of the distal reference lumen, plaque burden <50 % within 5 mm proximal or distal to stent edges, and absence of edge dissections involving the media and > 3 mm in length. The primary endpoint of target-vessel failure is a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization at 1 year. Secondary endpoints include the individual components of the primary end point as well as procedural and imaging endpoints. The IVUS CHIP UPP Registry is the first prospective investigation of procedural and clinical outcomes related to an IVUS-guided PCI for management of complex coronary lesions among minority patient populations in the United States. •Up to one third of patients undergoing percutaneous coronary interventions present with complex coronary lesions.•Complex coronary lesions are associated with higher rates of target vessel failure after percutaneous coronary interventions.•Optimization of procedural results with intravascular ultrasound has been associated with improved outcomes.•Baseline, procedural, and outcome findings will be investigated in minority patient populations in the US.