Terumo Europa. V.
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.
Cardiovascular Disease
Coronary Artery Occlusion
Ischemic Heart Disease
Ultimaster Nagomi™
The study is a prospective, multi-center, post-market, non-interventional, observational, single-arm study. Subjects with an indication for a PCI according to current European Society of Cardiology (ESC) or national guidelines will be treated with the Ultimaster Nagomi™ in accordance with the intended use. The PCI procedure will be per hospital routine including the option, as per physician preference, to assess the functional severity of the lesion, perform intra-coronary imaging, use lesion preparation devices or to perform a staged procedure. Also, post-procedural anti-platelet medication will be per ESC or national guidelines. The primary endpoint is Target Lesion Failure (TLF) defined as Cardiovascular Death (CD), Target-Vessel related Myocardial Infarction (TV-MI) and Clinically Driven Target Lesion Revascularization (CD-TLR) at 1 year. Secondary endpoints are a broad set of clinical endpoints defined by the Academic Research Consortium-II to fully characterize the performance of the Ultimaster Nagomi™ stent. Clinical events will be adjudicated by an independent Clinical Events Committee (CEC) to ensure a consistent assessment versus the event definitions. The Data Monitoring Committee (DMC) will simultaneously conduct regular review for accumulating data to ensure proper safety data monitoring. Core lab analysis of the baseline angiograms of bifurcation lesions by Quantitative Coronary Angiography (QCA) will be included. Procedural resource data will be collected for health-economic analysis. Subject reported outcomes will be documented using the EQ-5D-5L questionnaire and the Seattle Angina Questionnaire (SAQ) for the assessment of the quality of life and angina status, respectively. The study will enroll 3,000 patients from European sites. Follow-up will be 2 years, except for subjects in whom no Ultimaster Nagomi™ stent was implanted and subjects that do not meet the inclusion criteria for a complex PCI as ascertained after the index procedure. These subjects will be followed until discharge.}}
Study Type : | Observational |
Estimated Enrollment : | 3000 participants |
Official Title : | A Post-Market Clinical Follow-up Study With Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Subjects |
Actual Study Start Date : | April 25, 2023 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | September 2027 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Imelda Hospital
Bonheiden, Belgium,
Recruiting
C.H.U. Charleroi
Charleroi, Belgium,
Recruiting
Hospital East Limburg
Genk, Belgium,
Recruiting
CHR Citadelle
Liège, Belgium,
Recruiting
Saint-Luc Bouge Clinic
Namur, Belgium,
Recruiting
CHU UCL Mont Godinne Namur
See it, Belgium,
Recruiting
East Tallinn Central Hospital
Stable, Estonia,
Recruiting
Mater Private Network
Cork, Ireland,
Recruiting
Mater Private Hospital
Dublin, Ireland,
Recruiting
IRCCS Italian Auxological Institute
Milano, Italy,
Recruiting
Rijnstate Hospital
Arnhem, Netherlands,
Recruiting
Albert Schweitzer Hospital
Dordrecht, Netherlands,
Recruiting
Catharina Hospital Eindhoven
Eindhoven, Netherlands,
Recruiting
Medical Center Leeuwarden
Leeuwarden, Netherlands,
Recruiting
Maasstad Hospital
Rotterdam, Netherlands,
Recruiting
Jeroen Bosch Hospital
s-Hertogenbosch, Netherlands,
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain,
Recruiting
Juan Ramón Jiménez University Hospital
Huelva, Spain,
Not yet recruiting
Salamanca University Hospital
Salamanca, Spain,
Recruiting
Virgen del Rocio University Hospital
Sevilla, Spain,
Not yet recruiting
Basel University Hospital
Basel, Switzerland,
Recruiting
Cardiocentro Ticino Institute
Lugano, Switzerland,
Not yet recruiting
Royal Sussex County Hospital
Brighton, United Kingdom,
Recruiting
Lincolnshire Heart Centre Lincoln County Hospital
Lincoln, United Kingdom,
Not yet recruiting
Newcastle Freeman Hospital
Newcastle upon Tyne, United Kingdom,
Not yet recruiting
University Hospital Plymouth NHS trust
Plymouth, United Kingdom,
Recruiting
University Hospital of North Midlands
Staffordshire, United Kingdom,
Recruiting
Worcestershire Royal Hospital
Worcester, United Kingdom,