Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance

Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance - PROVISION study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049230

Enrollment

400

Registered

2022-10-16

Start date

2022-07-11

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

coronary artery disease

Interventions

Treatment based on FFRangio asesssment Treatment based on FFR asessment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients for whom PCI is appropriate 2)Lesions whose visual diameter stenosis is greater than or equal to 30% and less than 90% 3)Lesions whose visual reference vessel diameter is greater than or equal to 2mm

Exclusion criteria

Exclusion criteria: 1)Patients for whom PCI is not appropriate 2)Patients with within 72 hours of acute coronary syndrome 3)Patients with severe bronchial asthma or chronic obstructive pulmonary disease 4)Patients with heart failure categorized as NYHA class III or IV 5)Patients with allergy to contrast media

Design outcomes

Primary

Measure	Time frame
Revascularization rate based on angiography-derived fractional flow reserve compared to that based on fractional flow reserve	—

Secondary

Measure	Time frame
Adverse events after one year(cardiac death, myocardial infarction, ischemia-driven revascularization, stroke, hospitalization due to heart failure) Costs of cardiac catheterization and revascularization Costs of adverse events	—

Countries

Japan

Contacts

Public ContactToru Tanigaki

Gifu Heart Center Cardiology

tanigaki@heart-center.or.jp058-277-2277

Outcome results

None listed

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