COMparison of clinical outcomes Following percutaneous coronary intervention versus Optimal medical therapy based on gray zone fractional flow Reserve in sTABLE angina patients with intermediate coronary artery stenosis

UMIN ID: UMIN000031526

Registered date:01/03/2018

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: coronary artery disease
• Date of first enrollment: 2020/05/26
• Target sample size: 410
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

percutaneous coronary intervention (PCI) + medical therapy
medical therapy alone

Outcome(s)

• Primary Outcome: Major adverse cardiac events defined as a composite of death, non-fatal myocardial infarction, and unplanned target vessel revascularisation
• Secondary Outcome: - MACE at 2 and 5 years - death from any cause at 1, 2, and 5 years - cardiovascular death at 1, 2, and 5 years - target vessel myocardial infarction at 1, 2, and 5 years - non-target vessel myocardial infarction at 1, 2, and 5 years - all myocardial infarction at 1, 2, and 5 years - target vessel revascularisation at 1, 2, and 5 years - non-target vessel revascularisation at 1, 2, and 5 years - all revascularisation at 1, 2, and 5 years - stent thrombosis at 1, 2, and 5 years - angina symptom assessed by Canadian Cardiovascular Society (CCS) functional classification at 1, 2, and 5 years

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. culprit vessel in acute coronary syndrome 2. patients with untreated significant lesions (%DS>70 and/or FFR <0.75) in coronary arteries other than the target vessel. 3. unstable hemodynamics 4. hemodyalysis 5. previous bypass graft surgery 6. allergy to antiplatelet therapy, anticoagulants, and contrast medium 7. intracranial and/or gastrointestinal bleeding 8. planned surgical procedure within 12 months 9. Known terminal disease with a life expectancy of less than 12 months 10. pregnant women 11. significant valvular disease 12. 13.1. left main disease (%DS > 50%) or planned PCI to left main disease 13.2 chronic total occlusion 13.3 Heavily calcified or tortuous vessels where inability to cross the lesion with a pressure wire is expected. 13.4 diffuse diseases, heavily calcified lesions, small vessels, and/or aneurysmal lesions where PCI is thought to be unsuitable by operators.

Related Information

• Primary Sponsor: Wakayama Medical University
• Source(s) of Monetary Support: Seijin kekkanbyou kenkyu shinkou zaidan