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Japanese

Feb. 28, 2019

Aug. 18, 2026

jRCTs052180085

OPTIVUS-Complex PCI: Optimal Intravascular Ultrasound Guided Complex Percutaneous Coronary Intervention study (OPTIVUS-Complex PCI)

OPTIVUS-Complex PCI (OPTIVUS-Complex PCI)

Ono Koh

Kyoto University Graduate School of Medicine

Kawahara-cho 54, Shougoin, Sakyo-ku, Kyoto, Japan

+81-75-751-4254

kohono@kuhp.kyoto-u.ac.jp

Shiomi Hiroki

Kyoto University Hospital

Kawahara-cho 54, Shougoin, Sakyo-ku, Kyoto, Japan

+81-75-751-4255

hishiomi@kuhp.kyoto-u.ac.jp

Not Recruiting

Jan. 20, 2019

Mar. 08, 2019
2000

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who are planned to receive PCI for left main coronary artery or mulutivessel including left anterior descending artery

ST elevation myocardial infarction
Cardiogenic shock
Prior CABG
Patients who refuse to participate
Patients who are decided to be ineligible by attending physician

No limit
No limit

Both

Coronary artery disease

Performing PCI with an optimal goal of pre-defined IVUS criteria

major adverse cardiac and cerebrovascular events: MACCE

all-cause death/MI/Stroke
all-cause death
cardiac death
non-cardiac death
cardiovascular death
non-cardiovascular death
myocardial infarction
stent thrombosis
stroke
ischemic stroke
hemorrhagic stroke
target lesion revascularization (TLR)
target vessel revascularization (TVR)
any coronary revascularization
coronary artery bypass surgery (CABG)
hospital addmission due to unstable angina
hospital addmission due to VT/Vf
hospital addmission due to heart failure
major bleeding
non-CABG surgery

BOSTON SCIENTIFIC JAPAN
BOSTON SCIENTIFIC JAPAN
BOSTON SCIENTIFIC JAPAN
BOSTON SCIENTIFIC JAPAN
Kyoto University Certiffied Review Board
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Kyoto

+81-75-366-7618

ethcom@kuhp.kyoto-u.ac.jp
Approval

Feb. 04, 2019

No

none

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