The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.
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
. Age ≥ 18 years
. Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site
. Ischemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedure
. Intention to treat all lesions requiring a PCI with the Ultimaster Nagomi stent
. Multivessel PCI defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts treated with a stent
. ≥ 3 stents implanted
. ≥ 3 lesions treated
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.
. Complex bifurcation lesion defined as true bifurcation lesion (Medina 1.1.1, 1.0.1 or 0.1.1) with a side branch diameter ≥ 2.5 mm plus one of the following:
Exclusion criteria
. Any surgery requiring general anaesthesia, 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
. Hypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicated
. Known contrast sensitivity that cannot be premedicated
. Pregnant and breastfeeding women
. Life expectancy \< 1 year for any cardiac or non-cardiac cause
. Participation in another clinical study that has not yet completed its primary endpoint
. Earlier enrolment in the Nagomi Complex study
. Unlikely to be available for follow-up during the duration of the study (2 years)