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

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 ReviewBoard/Ethics Committee of the respective clinical site

3. Ischemic heart disease with an indication for a PCI with, if available and perhospital 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 arterialbypass 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, 1.0.1or 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 likelynecessitating the discontinuation of dual anti-platelet therapy before therecommended duration of dual anti-platelet therapy per the ESC or nationalguidelines

2. Hypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromiumalloy, sirolimus or its structurally related compounds, lactide polymers orcaprolactone 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 primaryendpoint

7. Earlier enrolment in the Nagomi Complex study

8. Unlikely to be available for follow-up during the duration of the study (2 years)