Comparison of Drug-Coated versus Conventional Balloonsfor the Side Branch of the Bifurcation Lesion- MULTICENTER RANDOMIZED CONTROLLED STUDY

Sakata Yasushi0 个研究点目标入组 300 人开始时间: 2020年10月28日最近更新: 2023年10月17日

适应症

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•Patients who satisfy all of the following inclusion criteria and none of the exclusion criteria are enrolled in the present study.
•1. Patients aged at least 20 years at the time of their consent
•2. Patients who agree to be enrolled in the study giving signed written informed consent
•3. Patients undergoing a first-time PCI in bifurcation
•4. Patients undergoing PCI in bifurcation with a side branch 2.0-3.0 mm in diameter
•5. Patients undergoing PCI in bifurcation which is intended to be treated with a single stenting strategy (DES implantation in only main branch)
•6. Patients who can receive dual antiplatelet therapy according to the latest guideline
•7. Patients who agree to receive coronary angiography 9 months after PCI

•Patients are excluded from this study if they have the following criteria.
•1. Patients who are pregnant or breast-feeding
•2. In-stent restenosis
•3. Lesion in the bypass graft
•4. Lesion with acute coronary syndrome
•5. Patients who developed acute myocardial infarction within 1 month
•6. Patients complicated with active bleeding
•7. Patients who are participating in intervention study, or who are participating or are scheduled to participate in clinical trial or clinical study with intervention before the end of the follow-up of the present study
•8. Life expectancy within 1 year
•9. Hemodialysis
•10. Lesion with total occlusion
•11. Patients who are judged as inappropriate subjects for the present study by the principal investigator or collaborators

发起方

Sakata Yasushi