LONG NAGOMI™ PMCF STUDY
Long Coronary Lesions: Safety and Performance of the Ultimaster Nagomi™ Stent in This Setting With a One-to-one Approach -One Lesion, One Stent- LONG NAGOMI™ PMCF STUDY
Fundación EPIC
1,039 participants
Feb 27, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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.
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Interventions
Patients in whom treatment with long nagomi has been attempted
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07399002