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

NCT ID: NCT05705973

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-25
• Study Completion Date: 2027-04-29

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.

Detailed Description

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.

Conditions

Cardiovascular Disease; Coronary Artery Occlusion; Ischemic Heart Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Austria; Belgium; Estonia; France; Ireland; Italy; Netherlands; Poland; Serbia; Spain; Sweden; Switzerland; United Kingdom

Other Identifiers

T137E4

Identifier Type: -

Identifier Source: org_study_id