ltimaster NagomiTM Sirolimus Eluting Coronary Stent System in Complex PCI Subjects

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 580

Inclusion Criteria

1) Age >= 18 years 2) Subject 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 in
the hospital, Heart Team consensus for a PCI procedure 4) Intention to treat
all lesions requiring a PCI with the Ultimaster NagomiTM stent 5) Subject meets
>= 1 of the complex procedure criteria: a) Multivessel PCI defined as >= 2 native
coronary arteries and/or venous or arterial bypass grafts treated with a stent
b) >= 3 stents implanted c) >= 3 lesions treated d) 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,
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
cobaltchromium 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 PMCF STUDY 8) Unlikely to
be available for follow-up during the duration of the study (2 years)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is Target Lesion Failure (TLF) defined as the composite of<br /><br>cardiovascular death, target-vessel related myocardial infarction and<br /><br>clinically driven target lesion revascularization at 1-year post-procedure.</p><br>

Secondary Outcome Measures