Japanese prospective observational study of 3D-OCT guided bifurcation PCI

Japanese prospective observational study of 3D-OCT guided bifurcation PCI - Japanese 3D-OCT Bifurcation Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026759

Enrollment

600

Registered

2017-04-01

Start date

2018-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patient with a de novo lesion in which stent will be implanted 2) Patient who has a side branch with visually confirmed luminal diameter of 2 mm or more 3) Age 20 years or older

Exclusion criteria

Exclusion criteria: 1) Patient who has a stent restenosis lesion in which stent will be implanted 2) Patient with cardiogenic shock 3) Patient with a STEMI and CTO lesion 4) Patient who is considered PCI not applicable 5) Patient whom physician in charge of the study determined not applicable

Design outcomes

Primary

Measure	Time frame
Bifurcation area restenosis within a year after PCI in the Optimal group with side branch dilatation, Suboptimal group and the group with no side branch dilatation. (50% or more stenosis progression from immediately after the clinical trial due to nature of coronary angiography)	—

Secondary

Measure	Time frame
Rate of major adverse cardiovascular events within 3 years after PCI. Cardiac death, non-cardiac death, myocardial infarction, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and renal dysfunction. <Exploratory parameter> An exploratory study on bifurcation stenting using 3D OCT imaging guide *Jailed strut pattern, success rate of optimal cell re-crossing, PCI procedure time, contrast usage, and fluoroscopy time.	—

Measure

Time frame

Rate of major adverse cardiovascular events within 3 years after PCI. Cardiac death, non-cardiac death, myocardial infarction, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and renal dysfunction. <Exploratory parameter> An exploratory study on bifurcation stenting using 3D OCT imaging guide *Jailed strut pattern, success rate of optimal cell re-crossing, PCI procedure time, contrast usage, and fluoroscopy time.

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Countries

Japan

Contacts

Public ContactRyoji Nagoshi

Osaka Saiseikai Nakatsu Hospital Cardiology

ryoji754@gmail.com06-6372-0333

Outcome results