NCT05705973Active, not recruiting
Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
A Post-Market Clinical Follow-up Study With Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Subjects
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3000 (actual)
- First submitted
- 9 Dec 2022
- Start date
- 25 Apr 2023
- Primary completion date
- 3 Jul 2026
- Lead sponsor
- Terumo Europe N.V.
- Diseases
- Coronary artery disease
- NCT number
- NCT05705973
What you commit to
- Study type: Observational
- Participants enrolled: 3000
- From 25 Apr 2023 to the primary completion date, 3 Jul 2026
- 52 sites in 13 countries
- 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
- 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
- Life expectancy \< 1 year for any cardiac or non-cardiac cause
Lab values
- 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
Other
- Known contrast sensitivity that cannot be premedicated
- Pregnant and breastfeeding women
- 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)
Criteria the registry did not label
- General 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
- Complex Procedure Inclusion Criteria
- Subject meets ≥ 1 of the complex procedure criteria:
- 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
- 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:
- side branch disease \> 10 mm ii) calcified lesion iii) thrombotic lesion
- Bifurcation lesion implanted with two stents
- Total stent length implanted \> 60 mm
- Chronic total occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least a 3-month duration
- Left main stenting (main stem and/or bifurcation)
- In-stent restenosis
- Severe calcified lesion with use of atherectomy, lithotripsy or cutting balloon
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Klagenfurt am Worthersee Coordinator of this site? Confirm its status | Klagenfurt | Austria | Unknown status |
| Imelda Hospital Coordinator of this site? Confirm its status | Bonheiden | Belgium | Unknown status |
| C.H.U. Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| Hôpital de Jolimont Coordinator of this site? Confirm its status | La Louvière | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHR Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Clinique Saint-Luc Bouge Coordinator of this site? Confirm its status | Namur | Belgium | Unknown status |
| CHU UCL Mont Godinne Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Luzerner Kantonsspital Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| Istituto Cardiocentro Ticino Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| East Tallinn Central Hospital Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Salamanca University Hospital Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Chu Jean Minjoz Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Hôpital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Clinique Louis Pasteur Coordinator of this site? Confirm its status | Essey-lès-Nancy | France | Unknown status |
| Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Privé Jacques Cartier Coordinator of this site? Confirm its status | Massy | France | Unknown status |
| Centre Hospitalier Universitaire de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Clinique Saint-Hilaire Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Lincolnshire Heart Centre Lincoln County Hospital Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Unknown status |
| London North West University Healthcare NHS Trus Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Altnagelvin Area Hospital Coordinator of this site? Confirm its status | Londonderry | United Kingdom | Unknown status |
| University Hospital of North Midlands Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Newcastle Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| University Hospital Plymouth NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Worcestershire Royal Hospital Coordinator of this site? Confirm its status | Worcester | United Kingdom | Unknown status |
| Mater Private Network Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
| Mater Private Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Galway University Hospital Coordinator of this site? Confirm its status | Galway | Ireland | Unknown status |
| Monzino Cardiology Center Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Rijnstate Ziekenhuis Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Unknown status |
| Catharina Hospital Eindhoven Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Medisch Centrum Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Unknown status |
| Maasstad Ziekenhuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Unknown status |
| Uniwersytecki Szpital Kliniczny w Poznaniu Oddział Kardiologii Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Dedinje Cardiovascular Institute Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Gävle Hospital Coordinator of this site? Confirm its status | Gävle | Sweden | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.