NCT07399002Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1039 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 27 Feb 2026
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT07399002
What you commit to
- Study type: Observational
- Planned participants: 1039
- From 27 Feb 2026 to the primary completion date, 1 Jan 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4).
- Patients with contraindications or hypersensitivity to sirolimus.
Lab values
- 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.
Other
- 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 a life expectancy of less than 2 years.
- Patients included in other clinical trials that did not reach the primary objective.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Cabueñes | Spain | Recruiting |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.