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.

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

Cardiovascular Disease

Coronary Artery Occlusion

Ischemic Heart Disease

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.

Ultimaster Nagomi™

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

Defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization.

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.

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).

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.

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.

The composite of cardiovascular death, MI (not clearly attributable to a nontarget vessel) and clinically driven Target lesion revascularization (TLR).

Defined as composite of all-cause mortality, any MI and any coronary revascularization.

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.

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.

Successful revascularization of all lesions with angiographically a diameter stenosis ≥ 50%

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

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)

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.

Number of devices used during the procedure and use of anti-platelet and anti-thrombotic medication during the follow-up period.

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.

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

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.

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

About this trial

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Placebo

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What is this trial about?

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