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

Not Applicable

Recruiting

• Conditions: coronary artery disease

• Registration Number: JPRN-UMIN000031526
• Lead Sponsor: Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-01
• Last Update Posted: 17 October 2023
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events defined as a composite of death, non-fatal myocardial infarction, and unplanned target vessel revascularisation

Secondary Outcome Measures

Name	Time	Method
- 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