Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience

Study Overview
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Brief Summary
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The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions. The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.

Official Title
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A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting

Conditions
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Coronary Stenosis

Intervention / Treatment
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* Device: Bifurcation stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient eligible for percutaneous coronary intervention Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%) Second vessel at coronary bifurcation treatable with trial device during the procedure True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1, Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch Target lesion treatable with one or two stents in both the main and side branches Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches Exclusion Criteria: A. General restrictions Unable to be followed by the implementing medial institution Life expectancy <1 year Acute myocardial infarction (<1 week) Left ventricular ejection fraction <30% Scheduled for elective treatment requiring antiplatelet drug Withdrawal Deemed as unsuitable by the investigator or subinvestigator Serum creatinine level ≥2.0 Mg/dl B. Vascular morphological restrictions Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting In-stent restenosis Severe calcification

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2-link stent Nobori<br>Bifurcation stenting | Device: Bifurcation stenting<br>* Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience<br>|
| Active Comparator: 3-link stent Xience<br>Bifurcation stenting | Device: Bifurcation stenting<br>* Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum lumen diameter of the side branch ostium in bifurcation |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACE |  | in-hospital, 30 days, 8 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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True Bifurcation stenosis