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
Abstract
Background
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.
Methods/design
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.