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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitario de Cabueñes
  Cabueñes, Spain Recruiting
• Hospital General Universitario de Ciudad Real
  Ciudad Real, Spain Recruiting
• Hospital General Universitario de Elche
  Elche, Spain Recruiting
• Hospital Universitario Juan Ramón Jiménez
  Huelva, Spain Recruiting
• Hospital Universitario de Leon
  León, Spain Recruiting
• Hospital Universitario Regional de Málaga
  Málaga, Spain Recruiting

Study contacts

• Study coordinator: TAMARA GARCIA CAMARERO, MD, PhD
• Email: tgcamarero@gmail.com
• Phone: 0034615420460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.