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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario de Cabueñes
Coordinator of this site? Confirm its status
CabueñesSpainRecruiting
Hospital General Universitario de Ciudad Real
Coordinator of this site? Confirm its status
Ciudad RealSpainRecruiting
Hospital General Universitario de Elche
Coordinator of this site? Confirm its status
ElcheSpainRecruiting
Hospital Universitario Juan Ramon Jimenez
Coordinator of this site? Confirm its status
HuelvaSpainRecruiting
Hospital Universitario De Leon
Coordinator of this site? Confirm its status
LeónSpainRecruiting
Hospital Universitario Virgen de la Victoria
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Universitario Regional de Málaga
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Universitario de Navarra
Coordinator of this site? Confirm its status
PamplonaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
Coordinator of this site? Confirm its status
SantanderSpainRecruiting
Hospital Universitario Virgen del Rocio
Coordinator of this site? Confirm its status
SevilleSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.