BMJ Open. 2026 Jul 7;16(7):e116572. doi: 10.1136/bmjopen-2026-116572.
ABSTRACT
INTRODUCTION: Percutaneous coronary intervention (PCI) has evolved significantly over the past decade with approximately 30% of patients presenting with complex coronary artery disease, posing heightened procedural and long-term risks. Complexity in PCI is increasingly recognised as multifactorial, encompassing lesion, procedural and patient-related characteristics. The Ultimaster Nagomi sirolimus-eluting coronary stent system is designed to address the challenges of complex PCI. The NAGOMI COMPLEX study aims to assess its safety and clinical performance in a comprehensively defined complex PCI population, reflecting routine clinical practice.
METHODS AND ANALYSIS: This is a prospective, multicentre, single-arm cohort study enrolling 3000 subjects undergoing complex PCI across 52 European sites. Eligible patients must meet at least one complex PCI criterion, such as multivessel PCI, bifurcation lesions, chronic total occlusions or long total stent length implantation (>60 mm). Patients will undergo PCI using the Ultimaster Nagomi sirolimus-eluting coronary stent system, with follow-up assessments conducted at 30 days, 6 months, 1 year and 2 years. The primary endpoint is Target Lesion Failure at 1 year, defined as a composite of cardiovascular death, target-vessel myocardial infarction and clinically driven target lesion revascularisation. Secondary endpoints include device success, lesion success, procedure success, rates of stent thrombosis, bleeding complications (Bleeding Academic Research Consortium (BARC 3-5)), patient-reported outcomes (EQ-5D-5L, Seattle Angina Questionnaire (SAQ-7)) and resource utilisation for health-economic analysis. Subgroup analyses will explore outcomes across clinical and procedural complexity criteria. Clinical events will be adjudicated by an independent Clinical Events Committee, while a Data Monitoring Committee will oversee safety.
ETHICS AND DISSEMINATION: The study complies with the Declaration of Helsinki, EU MDR 2017/745, ISO 14155:2020, EU Regulation 2016/679 (General Data Protection Regulation), GCP and applicable national regulations. Ethics Committee approval has been obtained at all participating sites. Written informed consent is required from all subjects. Results will be disseminated through peer-reviewed publications and scientific conferences.
TRIAL REGISTRATION NUMBER: NCT05705973.
PMID:42414012 | DOI:10.1136/bmjopen-2026-116572