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NCT05705973

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

Sponsor: Terumo Europe N.V.

View on ClinicalTrials.gov

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.

Official title: A Post-Market Clinical Follow-up Study With Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2023-04-25

Completion Date

2027-04-29

Last Updated

2025-05-20

Healthy Volunteers

Conditions

Cardiovascular Disease Coronary Artery Occlusion Ischemic Heart Disease

Interventions

DEVICE

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

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)

Locations (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