OCVC-BIF

JRCT ID: jRCTs052200077

Registered date:28/10/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: stable coronary artery disease
• Date of first enrollment: 16/11/2020
• Target sample size: 300
• Study type: Interventional

Intervention(s)

Subject: Patients undergoing initial PCI in bifurcation lesion of the native coronary artery which is intended to be treated with DES implantation in only main branch followed by kissing balloon inflation
- DCB group (experimental arm): Additional inflation for side branch with drug-coated balloon
- CB group (control arm): No additional treatment

Outcome(s)

• Primary Outcome: Restenosis rate of side branch evaluated by QCA 9 months after PCI

Secondary Outcome

1. Diameter stenosis of side branch by QCA 9 months after PCI
2. Revascularization rate of side branch 12 month after PCI
3. Procedure success rate
4. Procedure-related complication rate
5. Clinical outcomes 12 months after PCI: Major adverse cardiac event (defined as a composite of cardiac death, acute myocardial infarction, target lesion revascularization, stent thrombosis), cardiac death, acute myocardial infarction, target lesion revascularization, stent thrombosis
6. Late lumen loss of side branch ostium by OCT from immediately after PCI to 9 months after PCI
7. Late lumen loss volume of side branch by OCT from immediately after PCI to 9 months after PCI
8. Frequency of malapposed struts 9 months after PCI
9. Frequency of uncovered struts 9 months after PCI
10. Malapposition volume 9 months after PCI
11. Incidence of thrombus attachment 9 months after PCI

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Sakata Yasushi
• Secondary Sponsor: Ishihara Takayuki
• Source(s) of Monetary Support: Nipro Corporation
• Secondary ID(s): Nil known