OPTIVUS-Complex PCI

JRCT ID: jRCTs052180085

Registered date:28/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Coronary artery disease
• Date of first enrollment: 08/03/2019
• Target sample size: 2000
• Study type: Interventional
• Intervention(s): Performing PCI with an optimal goal of pre-defined IVUS criteria

Outcome(s)

• Primary Outcome: major adverse cardiac and cerebrovascular events: MACCE

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who are planned to receive PCI for left main coronary artery or mulutivessel including left anterior descending artery

Exclude criteria

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

Related Information

• Primary Sponsor: Ono Koh
• Secondary Sponsor: Kimura Takeshi
• Source(s) of Monetary Support: BOSTON SCIENTIFIC JAPAN,BOSTON SCIENTIFIC JAPAN,BOSTON SCIENTIFIC JAPAN,BOSTON SCIENTIFIC JAPAN