Skip to content

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

Long-term outcomes of Japanese patients with deferral of coronary intervention based on fractional flow reserve in multicenter registry - J-CONFIRM Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000014473
Enrollment
1200
Registered
2014-07-07
Start date
2013-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stable angina pectoris and unstable angina pectoris

Interventions

None listed

Sponsors

Physiological PCI Live Demonstration Office
Lead Sponsor
Volcano Japan corporation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (I) Patients were clinically suspected of angina pectoris and underwent coronary angiography. (II) Coronary angiography showed more than 50% diameter stenosis by visual estimation and FFR examination was done. (III) Patients fulfilled (I),(II) and any one of the following criteria: 1) defered PCI based on FFR >0.80; 2) underwent PCI regardless of FFR >0.80; and 3) defered PCI regardless of FFR ≤0.80.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactShoichi Kuramitsu

Kokura Memorial Hospital Cardiology

kuramitsu@circulation.jp093-511-2000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026