Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
NAGOMI COMPLEX
A Post-Market Clinical Follow-up Study With Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Subjects
1 other identifier
observational
3,000
11 countries
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedStudy Start
First participant enrolled
April 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2027
ExpectedMay 20, 2025
May 1, 2025
3 years
December 9, 2022
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure (TLF)
Defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization.
at 1-year post procedure
Secondary Outcomes (16)
Delivery success
Intraoperative
Lesion success
Intraoperative
Device success
Intraoperative
Procedure success
during hospitalization, approximately 3 days
Target lesion failure (TLF)
at index procedure, 30 days, 6 months, 1 year, and 2 years
- +11 more secondary outcomes
Interventions
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
Eligibility Criteria
Subjects who have signed the informed consent are considered enrolled upon insertion of the first Ultimaster NagomiTM stent is successfully implanted and the complex procedure criteria are confirmed. It is expected that study enrolment will take approximately 1.5 years. Enrolment will be competitive, i.e. enrolment will be closed once the total number of subjects has been reached irrespective of the number of subjects per individual site. Individual sites can not enroll more than 300 subjects. The enrolled patient population is expected to be representative for complex patients because of the limited exclusion criteria and the participation of multiple sites from across Europe
You may qualify if:
- 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
- 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:
- 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
- +1 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
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
Karolinska University Hospital
Huddinge, Sweden
Universitätsspital Basel
Basel, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Istituto Cardiocentro Ticino
Lugano, Switzerland
Royal Sussex County Hospital
Brighton, United Kingdom
Lincolnshire Heart Centre Lincoln County Hospital
Lincoln, United Kingdom
London North West University Healthcare NHS Trus
London, United Kingdom
Altnagelvin Area Hospital
Londonderry, United Kingdom
University Hospital of North Midlands
Newcastle, United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, United Kingdom
University Hospital Plymouth NHS trust
Plymouth, United Kingdom
Worcestershire Royal Hospital
Worcester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
January 31, 2023
Study Start
April 25, 2023
Primary Completion
April 29, 2026
Study Completion (Estimated)
April 29, 2027
Last Updated
May 20, 2025
Record last verified: 2025-05