CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 1,942 target
Drug / intervention
Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06218485
NCT06218485N/ARecruitingOn TrackUpdated 16mo ago

Comparison of Fractional Flow Reserve-Guided Strategy Versus Intravascular Ultrasound-Guided Stent Implantation After Angiography-Derived Fractional Flow Reserve-based Decision-Making (The FLAVOUR III Trial)

Second Affiliated Hospital, School of Medicine, Zhejiang University·interventional·Posted Jan 23, 2024·Updated Feb 24, 2025

In Brief

A clinical study evaluating Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making and Fractional flow reserve-guided PCI strategy for Coronary Artery Disease. Currently recruiting, targeting 1,942 participants across 25 sites in 2 countries.

Detailed Summary

To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.

Study Details

Timeline

N/ARecruiting
2024202520262027202820292030
First PostedJan 23, 2024
Enrollment StartMar 13, 2024
Primary CompletionDec 1, 2027
Study CompletionDec 1, 2029
TodayJul 1, 2026
Enrollment to primary: 3.7 yearsPosted 2.4 years agoPrimary completion in 1.4 years

Interventions

Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-makingprocedure

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making: 1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80. 2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area

Fractional flow reserve-guided PCI strategyprocedure

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy: 1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80. 2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05