LONG NAGOMI™ PMCF STUDY (NCT07399002) | Clinical Trial Compass
RecruitingNot Applicable
LONG NAGOMI™ PMCF STUDY
Spain1,039 participantsStarted 2026-02-27
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.