Overview
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ \_stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according to the indications approved in the CE marking.
Description
The study serves to fulfill post marketing surveillance requirements for the Ultimaster Nagomi™ stent. This is a PMCF study of real-world use of the Ultimaster Nagomi™ DES aimed to reaffirm the device claims of effectiveness and safety, no comparator is required to meet these specified objectives and endpoints.
Eligibility
Inclusion Criteria:
- Patients who meet ALL inclusion criteria will be included:
- Patients aged ≥ 18 years AND;
- Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND;
- Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND;
- Patients who have been informed of the characteristics of the study and have provided written informed consent AND;
- Intention to treat all lesions with the Ultimaster Nagomi™ stent
Exclusion Criteria:
- Patients must not meet any of the following exclusion criteria:
- Patients who expressly decline to participate in the study.
- Pregnant or breastfeeding women.
- Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4).
- Patients with contraindications or hypersensitivity to sirolimus.
- Patients with a life expectancy of less than 2 years.
- Patients in whom any surgery requiring general anesthesia is planned, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines.
- Patients included in other clinical trials that did not reach the primary objective.
