Coronary Stenosis
Conditions
Keywords
True Bifurcation stenosis
Brief summary
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.
Interventions
DEVICEBifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
Sponsors
Kurashiki Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient eligible for percutaneous coronary intervention 2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence 3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%) 4. Second vessel at coronary bifurcation treatable with trial device during the procedure 5. 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, 6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch 7. Target lesion treatable with one or two stents in both the main and side branches 8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery 9. Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches
Exclusion criteria
A. General restrictions 1. Unable to be followed by the implementing medial institution 2. Life expectancy \<1 year 3. Acute myocardial infarction (\<1 week) 4. Left ventricular ejection fraction \<30% 5. Scheduled for elective treatment requiring antiplatelet drug Withdrawal 6. Deemed as unsuitable by the investigator or subinvestigator 7. Serum creatinine level ≥2.0 Mg/dl B. Vascular morphological restrictions 1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting 2. In-stent restenosis 3. Severe calcification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum lumen diameter of the side branch ostium in bifurcation | 8 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of MACE | in-hospital, 30 days, 8 months, 1 year |
Countries
Japan
Outcome results
None listed