LONG NAGOMI™ PMCF STUDY

Recruiting now

Conditions studied: Coronary Artery Disease, Ischemic Heart Disease

In brief

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.

Key facts

Study ID

NCT07399002

Run by

Fundación EPIC

People needed

1039

Starts

2026-02-27

Expected to finish

2029-01-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hospital Universitario de Cabueñes — Cabueñes, Spain (enrolling)
• Hospital General Universitario de Elche — Elche, Spain (enrolling)
• Hospital Universitario Juan Ramón Jiménez — Huelva, Spain (enrolling)
• Hospital Universitario de Leon — León, Spain (enrolling)
• Hospital Universitario Regional de Málaga — Málaga, Spain (enrolling)
• Hospital Universitario de Navarra — Pamplona, Spain (enrolling)
• Hospital Universitario Marqués de Valdecilla — Santander, Spain (enrolling)

Full record on ClinicalTrials.gov

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