Clinical trial NCT05705973: Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
Official title: A Post-Market Clinical Follow-up Study With Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Subjects
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Disease
Coronary Artery Occlusion
Ischemic Heart Disease
Keywords: Percutaneous Coronary Intervention
Complex Bifurcation Lesion
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2023-01-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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 outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: at 1-year post procedure
Secondary outcomes:
measure: Delivery success
timeFrame: Intraoperative
measure: Lesion success
timeFrame: Intraoperative
measure: Device success
timeFrame: Intraoperative
measure: Procedure success
timeFrame: during hospitalization, approximately 3 days
measure: Target lesion failure (TLF)
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Patient oriented composite endpoint (POCE)
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Death and subclassifications
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Myocardial infarction and subclassifications
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Revascularization and subclassifications
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Stent thrombosis (ST) and subclassifications
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Bleeding (Bleeding Academic Research Consortium (BARC) 3-5)
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Balance between bleeding (BARC 3-5) and thrombotic event (myocardial infarction and/or stent thrombosis)
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Utilization of cardiovascular health care resources
timeFrame: at index procedure, 30 days, 6 months, 1 year, and 2 years
measure: Quality of Life assessment
timeFrame: at baseline, 30 days, 6 months, 1 year, and 2 years
measure: Angina status assessment Seattle Angina Questionnaire (SAQ)
timeFrame: at baseline, 30 days, 6 months, 1 year, and 2 years
measure: QCA of the index procedure angiogram for a subset of patients with a Complex Bifurcation Lesion (CBL)
timeFrame: procedure
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Charleroi
country: Belgium
facility: C.H.U. Charleroi
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: La Louvière
country: Belgium
facility: Hopital de Jolimont
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHR Citadelle
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
city: Yvoir
country: Belgium
facility: CHU UCL Mont Godinne Namur
city: Tallin
country: Estonia
facility: East Tallinn Central Hospital
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Essey-lès-Nancy
country: France
facility: Clinique Louis Pasteur
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: Clinique Pasteur
city: Cork
country: Ireland
facility: Mater Private Network
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Milano
country: Italy
facility: IRCCS Istituto Auxologico Italiano
city: Milan
country: Italy
facility: Monzino Cardiology Center
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: s-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Poznań
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu Oddział Kardiologii
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: León
country: Spain
facility: Hospital Universitario de León
city: Salamanca
country: Spain
facility: Salamanca University Hospital
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Lugano
country: Switzerland
facility: Istituto Cardiocentro Ticino
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Derry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: Lincoln
country: United Kingdom
facility: Lincolnshire Heart Centre Lincoln County Hospital
city: London
country: United Kingdom
facility: London North West University Healthcare NHS Trus
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle Freeman Hospital
city: Newcastle
country: United Kingdom
facility: University Hospital of North Midlands
city: Plymouth
country: United Kingdom
facility: University Hospital Plymouth NHS trust
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
Study officials:
References: