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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Disease; Ischemic Heart Disease; Coronary Artery Occlusion
• Intervention / Treatment: Device: Ultimaster Nagomi™

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.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Evelyne Vicca; Phone Number: +32 16 381284; Email: evelyne.vicca@terumo-europe.com

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Hospital
    • Principal Investigator: Willem Dewilde
  • Charleroi, Belgium
    • Recruiting
    • C.H.U. Charleroi
    • Principal Investigator: Adel Aminian
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Principal Investigator: Ferdinande Bert
  • Liège, Belgium
    • Recruiting
    • CHR Citadelle
    • Principal Investigator: Georges Saad
  • Namur, Belgium
    • Recruiting
    • Clinique Saint-Luc Bouge
    • Principal Investigator: François Simon
  • Yvoir, Belgium
    • Recruiting
    • CHU UCL Mont Godinne Namur
    • Principal Investigator: Antoine Guédès
• Estonia
  • Tallin, Estonia
    • Recruiting
    • East Tallinn Central Hospital
• Ireland
  • Cork, Ireland
    • Recruiting
    • Mater Private Network
    • Principal Investigator: Ronan Margey
  • Dublin, Ireland
    • Recruiting
    • Mater Private Hospital
    • Principal Investigator: Robert Byrne
• Italy
  • Milano, Italy
    • Recruiting
    • IRCCS Istituto Auxologico Italiano
    • Principal Investigator: Paolo Sganzerla
• Netherlands
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate Ziekenhuis
    • Principal Investigator: Ron Pisters
  • Dordrecht, Netherlands
    • Recruiting
    • Albert Schweitzer Ziekenhuis
    • Principal Investigator: Rohit Oemrawsingh
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Hospital Eindhoven
    • Principal Investigator: Koen Teeuwen
  • Leeuwarden, Netherlands
    • Recruiting
    • Medisch Centrum Leeuwarden
    • Principal Investigator: Sjoerd Hofma
  • Rotterdam, Netherlands
    • Recruiting
    • Maasstad Ziekenhuis
    • Principal Investigator: Valeria Paradies
  • s-Hertogenbosch, Netherlands
    • Recruiting
    • Jeroen Bosch Ziekenhuis
    • Principal Investigator: Jawed Polad
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Principal Investigator: Dabit Arzamendi
  • Huelva, Spain
    • Recruiting
    • Hospital Universitario Juan Ramon Jimenez
    • Principal Investigator: Antonio Enrique Gómez Menchero
  • Salamanca, Spain
    • Not yet recruiting
    • Salamanca University Hospital
    • Principal Investigator: Ignacio Cruz González
  • Sevilla, Spain
    • Recruiting
    • Hospital Universitario Virgen Del Rocio
    • Principal Investigator: José Francisco Diaz Fernández
• Switzerland
  • Basel, Switzerland
    • Not yet recruiting
    • Universitätsspital Basel
    • Principal Investigator: Gregor Leibundgut
  • Lugano, Switzerland
    • Recruiting
    • Istituto Cardiocentro Ticino
    • Principal Investigator: Marco Valgimigli
• United Kingdom
  • Brighton, United Kingdom
    • Not yet recruiting
    • Royal Sussex County Hospital
    • Principal Investigator: David Hildick-Smith
  • Lincoln, United Kingdom
    • Recruiting
    • Lincolnshire Heart Centre Lincoln County Hospital
    • Principal Investigator: Kelvin Lee
  • Newcastle upon Tyne, United Kingdom
    • Not yet recruiting
    • Newcastle Freeman Hospital
    • Principal Investigator: Rajiv Das
  • Plymouth, United Kingdom
    • Not yet recruiting
    • University Hospital Plymouth NHS Trust
    • Principal Investigator: Girish Viswanathan
  • Staffordshire, United Kingdom
    • Recruiting
    • University Hospital of North Midlands
    • Principal Investigator: Mamas Mamas
  • Worcester, United Kingdom
    • Recruiting
    • Worcestershire Royal Hospital
    • Principal Investigator: Helen Routledge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 disease defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts with a lesion requiring PCI
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) Instent restenosis j) Severe calcified lesion with use of atherectomy or lithotripsy

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. An acute or evolving STEMI < 72 h after symptom onset
3. 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
4. Known contrast sensitivity that cannot be premedicated
5. Pregnant and breastfeeding women
6. Life expectancy < 1 year for any cardiac or non-cardiac cause
7. Participation in another clinical study that has not yet completed its primary endpoint
8. Earlier enrolment in the Nagomi Complex study
9. Unlikely to be available for follow-up during the duration of the study (2 years)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery success	Delivery success is defined as an achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter.	Intraoperative
Lesion success	Lesion success is defined as the attainment of < 30% residual stenosis by visual estimate and/or < 50% (by QCA) using any percutaneous method (if QCA was not available, the visual estimate of diameter stenosis is used).	Intraoperative
Device success	Device Success is defined as delivery success with the achievement of a final residual diameter stenosis of the target lesion of < 30% by visual assessment and/or < 50% by QCA, using the assigned device only.	Intraoperative
Procedure success	Procedure Success is defined as the achievement of < 30% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave, or repeat revascularization of the target lesion during the hospital stay.	during hospitalization, approximately 3 days
Target lesion failure (TLF)	The composite of cardiovascular death, MI (not clearly attributable to a nontarget vessel) and clinically driven Target lesion revascularization (TLR).	at index procedure, 30 days, 6 months, 1 year, and 2 years
Patient oriented composite endpoint (POCE)	Defined as composite of all-cause mortality, any MI and any coronary revascularization.	at index procedure, 30 days, 6 months, 1 year, and 2 years
Death and subclassifications	Death may be subclassified as: Cardiovascular death, Noncardiovascular death or Undetermined death. Cardiovascular death may include death caused by acute MI, death caused by sudden cardiac death, including unwitnessed, death resulting from heart failure, death caused by stroke, death caused by cardiovascular procedures, death resulting from cardiovascular hemorrhage, death resulting from other cardiovascular cause. Noncardiovascular death may include death from malignancy, death resulting from pulmonary causes, death caused by infection (including sepsis), death resulting from gastrointestinal causes, death resulting from accident/trauma, death caused by other noncardiovascular organ failure, death resulting from other. Undetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents.	at index procedure, 30 days, 6 months, 1 year, and 2 years
Myocardial infarction and subclassifications	Myocardial infarction - Absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit, plus 1 (or more) of the following criteria: New significant* Q waves or equivalent; Flow-limiting angiographic complications; New "substantial" loss of myocardium on imaging * Q-wave criteria requires the development of new Q waves ≥40 ms in duration and ≥1 mm deep in voltage in ≥2 contiguous leads.	at index procedure, 30 days, 6 months, 1 year, and 2 years
Revascularization and subclassifications	Successful revascularization of all lesions with angiographically a diameter stenosis ≥ 50%	at index procedure, 30 days, 6 months, 1 year, and 2 years
Stent thrombosis (ST) and subclassifications	Definite ST Presence of a thrombus that originates in the stent/scaffold or in the segment 5mm prox. or dist. to the stent/scaffold or in a side branch originating from the stented/scaffolded segment & at least 1 of the ff: Acute onset of ischemic symptoms at rest New ECG changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers Or Pathological confirmation of thrombosis Evidence of recent thrombus within the stent/scaffold determined at autopsy Examination of tissue retrieved ff. thrombectomy Probable ST Any MI that is related to documented acute ischemia in the territory of the implanted stent/scaffold w/out angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause. Occlusive thrombus Thrombolysis in MI grade 0/1 flow w/in or prox. to a stent/scaffold segment. Nonocclusive thrombus Intracoronary thrombus defined as a noncalcified filling defect or lucency surrounded by contrast material seen in mu	at index procedure, 30 days, 6 months, 1 year, and 2 years
Bleeding (Bleeding Academic Research Consortium (BARC) 3-5)	Type 3:Clinical, lab, and/or imaging evidence of bleeding w/ specific healthcare provider responses, as below: Type 3a Any BT with overt bleeding Overt bleeding plus Hgb drop ≥3 to < 5 g/dL Type 3b Overt bleeding plus Hgb drop ≥5 g/dL Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring IV vasoactive drugs Type 3c Intracranial hemorrhage Type 4:CABG-related bleeding Perioperative intracranial bleeding w/in 48 hr Reoperation after closure of sternotomy for bleeding control Transfusion of ≥5 U whole blood or packed RBC w/in a 48-hr period Chest tube output ≥2 L w/in a 24-hr period Type 5:Fatal bleeding Bleeding that directly causes death with no other explainable cause. Categorized as: Type 5a Probable bleeding that is clinically suspicious as the cause of death, but bleeding is not directly observed and no autopsy or confirmatory imaging. Type 5b Definite bleeding that is directly observed (clinical specimen or imaging)	at index procedure, 30 days, 6 months, 1 year, and 2 years
Quality of Life assessment	Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire: The first part of the questionnaire contain descriptive questions on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, each with 5 levels of responses. The second part of the questionnaire contains a standard vertical 20-cm visual analog scale that is calibrated from 'the worst health you can imagine' (scored 0) at its base to 'the best health you can imagine' (scored 100) at its apex.	at baseline, 30 days, 6 months, 1 year, and 2 years
QCA of the index procedure angiogram for a subset of patients with a Complex Bifurcation Lesion (CBL)	Luminal dimensions of bifurcation lesions will be measured by off-line quantitative coronary angiography by a central core laboratory. The objective of the QCA is to quantitate and express the benefit of the Proximal Optimisation Technique (POT). The POT balloon positioning is of importance in this technique as well as the balloon diameter to obtain optimal stent apposition in the main branch.	procedure
Balance between bleeding (BARC 3-5) and thrombotic event (myocardial infarction and/or stent thrombosis)	The number of patients with a BARC 3-5 bleeding in comparison to the number of patients with a myocardial infarction and/or a stent thrombosis.	at index procedure, 30 days, 6 months, 1 year, and 2 years
Utilization of cardiovascular health care resources	Number of devices used during the procedure and use of anti-platelet and anti-thrombotic medication during the follow-up period.	at index procedure, 30 days, 6 months, 1 year, and 2 years
Angina status assessment Seattle Angina Questionnaire (SAQ)	Angina status will be assessed through the Seattle Angina Questionnaire (SAQ). The SAQ is a validated disease-specific instrument for assessing the health status of patients with coronary artery disease. Scoring: Scores range from 1-100 with higher scores indicating better health	at baseline, 30 days, 6 months, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: Terumo Europe N.V.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Complex Bifurcation Lesion
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Coronary Occlusion
• Other Study ID Numbers: T137E4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No