LONG NAGOMI PMCF: follow-up of the Ultimaster Nagomi stent in long coronary artery lesions

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

This project tests the Ultimaster Nagomi drug-eluting stent in adults undergoing PCI for long coronary lesions to collect real-world safety and effectiveness data.

Quick facts

• Study type: Observational
• Enrollment: 1039 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación EPIC (Academic / other)
• Locations: 6 sites (Cabueñes and 5 other locations)
• Trial ID: NCT07399002 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, observational post-market clinical follow-up (PMCF) of the Ultimaster Nagomi sirolimus-eluting stent in patients treated according to its CE-marked indications. The registry enrolls adults with at least one lesion meeting predefined long-lesion criteria intended for a single long-stent approach (available in 38, 44 and 50 mm lengths). There is no comparator arm; patients are treated per routine clinical practice and followed to capture safety and effectiveness outcomes that reaffirm device claims. Data are collected across participating Spanish university hospitals to fulfill post-marketing surveillance obligations.

Who should consider this trial

Good fit: Adults (≥18 years) who are planned for PCI and have at least one long coronary lesion suitable for treatment with a single Ultimaster Nagomi stent and who can provide informed consent are the ideal candidates.

Not a fit: Patients in cardiogenic shock (Killip class 4), those with contraindication or hypersensitivity to sirolimus, pregnant or breastfeeding women, or patients whose lesions are not suitable for a single long stent are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could confirm that the long-length Ultimaster Nagomi stent is a safe and effective option for treating long coronary lesions, giving clinicians and patients greater confidence in its use.

How similar studies have performed: Previous clinical registries and trials of the Ultimaster platform and other sirolimus-eluting stents have shown favorable safety and efficacy, but long-length-specific PMCF data remain more limited and this study aims to add that evidence.

Eligibility criteria

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.

Where this trial is running

Cabueñes and 5 other locations

• Hospital Universitario de Cabueñes — Cabueñes, Spain (Recruiting)
• Hospital General Universitario de Elche — Elche, Spain (Recruiting)
• Hospital Universitario de Leon — León, Spain (Recruiting)
• Hospital Universitario Regional de Málaga — Málaga, Spain (Recruiting)
• Hospital Universitario de Navarra — Pamplona, Spain (Recruiting)
• Hospital Universitario Marqués de Valdecilla — Santander, Spain (Recruiting)

Study contacts

• Study coordinator: TAMARA GARCIA CAMARERO, MD, PhD

Conditions Coronary Artery Disease; Ischemic Heart Disease; MDR; PMCF