ong-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry

Not Applicable

Recruiting

• Conditions: stable angina pectoris and unstable angina pectoris

• Registration Number: JPRN-UMIN000014473
• Lead Sponsor: Physiological PCI Live Demonstration Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

1) ST and non-ST elevated myocardial infarction 2) emergent percutaneous coronary intervention 3) cardiogenic shock (Killip class IV) 4) lesion with chronic total occlusion 5) limited life expectancy due to cancer 6) inability to give informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is target vessel failure (TVF) at 2-year. TVFis defined as a composite of cardiac death related to target vessel, myocardial infarction, and clinically driven target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
1) Annual TVF at 1, 2, 3, 4, and 5 years 2) Annual Major Adverse Cardiac and Cerebrovascular Events (MACCE) and in-stent thrombosis at 1, 2, 3, 4, and 5 years 3) Annual MACCE according to success of coronary risk factor management control via pharmacotherapy at 1, 2, 3, 4, and 5 years 4) Annual MACCE for dialysis cases at 1, 2, 3, 4, and 5 years 5) Annual MACCE for stented and non-stent (de novo) lesions at 1, 2, 3, 4, and 5 years 6) Annual MACCE for diabetes and non-diabetes cases at 1, 2, 3, 4, and 5 years 7) Factorial analysis of patient background of MACCE event group and non-event group 8) Sub-group analysis of Annual MACCE rates for PCI group, DEFER group and Non-PCI group at 1, 2, 3, 4, and 5 years 9) Annual MACCE sub-grouped by iFR measurement (optional measurement item) at 1, 2, 3, 4, and 5 years *MACCE is defined as all mortality, non-fatal MI, stroke, and Clinically driven PCI or CABG.