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Clinical Trials in the UK / NCT05705973
Active, not recruiting Observational

Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

NCT05705973 · tracked via the Priya Life Science UK tracker
Sponsor
Terumo Europe N.V.
Phase
Observational
Started
2023-04-25
Last updated
2026-07-10

Condition(s) studied

Cardiovascular DiseaseCoronary Artery OcclusionIschemic Heart Disease

Investigational drug(s) / intervention(s)

Ultimaster Nagomi™

Ultimaster Nagomi™: The Ultimaster NagomiTM Sirolimus eluting coronary stent system with Rapid Exchange Balloon Delivery System consists of a balloon expandable intra-coronary L605 cobalt chromium (CoCr) stent with abluminal drug eluting coating, that consists of a blend of Sirolimus and Poly(D,L-lactide-co-caprolactone), pre-mounted onto a high pressure, semi-compliant balloon delivery catheter

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
General Inclusion Criteria: 1. Age ≥ 18 years 2. 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 3. Ischemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedure 4. 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: 1. Multivessel PCI defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts treated with a stent 2. ≥ 3 stents implanted 3. ≥ 3 lesions treated 4. 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: i) side branch disease \> 10 mm ii) calcified lesion iii) thrombotic lesion e) Bifurcation lesion implanted with two stents f) Total stent length implanted \> 60 mm g) Chronic total occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least a 3-month duration h) Left main stenting (main stem and/or bifurcation) i) In-stent restenosis j) Severe calcified lesion with use of atherectomy, lithotripsy or cutting balloon Exclusion Criteria: 1. 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 2. 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 3. Known contrast sensitivity that cannot be premedicated 4. Pregnant and breastfeeding women 5. Life expectancy \< 1 year for any cardiac or non-cardiac cause 6. Participation in another clinical study that has not yet completed its primary endpoint 7. Earlier enrolment in the Nagomi Complex study 8. Unlikely to be available for follow-up during the duration of the study (2 years)

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Klinikum Klagenfurt am Wörthersee Klagenfurt Austria
Imelda Hospital Bonheiden Belgium
C.H.U. Charleroi Charleroi Belgium
Ziekenhuis Oost-Limburg Genk Belgium
Hopital de Jolimont La Louvière Belgium
UZ Leuven Leuven Belgium
CHR Citadelle Liège Belgium
Clinique Saint-Luc Bouge Namur Belgium
CHU UCL Mont Godinne Namur Yvoir Belgium
East Tallinn Central Hospital Tallinn Estonia
CHU Jean Minjoz Besançon France
Hôpital Louis Pradel Bron France
Clinique Louis Pasteur Essey-lès-Nancy France
Hôpital de la Croix Rousse Lyon France
Hôpital Privé Jacques Cartier Massy France
Centre Hospitalier Universitaire de Nîmes Nîmes France
Clinique Saint-Hilaire Rouen France
Hôpital Foch Suresnes France
Clinique Pasteur Toulouse France
Mater Private Network Cork Ireland
Mater Private Hospital Dublin Ireland
Galway University Hospital Galway Ireland
Monzino Cardiology Center Milan Italy
IRCCS Istituto Auxologico Italiano Milan Italy
Jeroen Bosch Ziekenhuis 's-Hertogenbosch Netherlands
Rijnstate Ziekenhuis Arnhem Netherlands
Albert Schweitzer Ziekenhuis Dordrecht Netherlands
Catharina Hospital Eindhoven Eindhoven Netherlands
Medisch Centrum Leeuwarden Leeuwarden Netherlands
Maasstad Ziekenhuis Rotterdam Netherlands
Uniwersytecki Szpital Kliniczny w Poznaniu Oddział Kardiologii Poznan Poland
Dedinje Cardiovascular Institute Belgrade Serbia
University Clinical Center of Serbia Belgrade Serbia
Bellvitge University Hospital Barcelona Spain
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital Universitario Juan Ramón Jiménez Huelva Spain
Hospital Universitario de León León Spain
Salamanca University Hospital Salamanca Spain
Hospital Universitario Virgen del Rocio Seville Spain
Gävle Hospital Gävle Sweden

+ 12 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05705973 on ClinicalTrials.gov ↗ ← All trials in the UK