NCT02673424

Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis

Comparison of Clinical Outcomes Between Imaging and Physiology-guided Intervention Strategy in Patients With Intermediate Stenosis: Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis (FLAVOUR)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,700 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous coronary intervention (PCI) strategy with IVUS (intravascular ultrasound \[IVUS\])-guided PCI in patients with intermediate coronary stenosis.

Detailed description

1. Study overview This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- or imaging-guided PCI in patients with intermediate coronary stenosis. The primary hypothesis is that FFR-guided strategy will show non-inferior rate of patients-oriented composite outcomes (POCO) at 24 months after randomization, compared with IVUS-guided strategy in patients with intermediate coronary stenosis. 2. Study population and sample size calculation Sample Size Calculation Based on the event rates of previous trials, investigators predicted the rates of POCO at 24 months after PCI will be 10% in the FFR-guided arm, and 12% in the IVUS-guided arm. * Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any repeat revascularization) at 24 months after PCI * Design: non-inferiority , delta = 2.5% * Sampling ratio: FFR-guided strategy : IVUS-guided strategy = 1:1 * Type I error (α): One-sided 5% * Accrual time : 2 years * Total time : 4 years (accrual 2 year + follow-up 2 years) * Assumption: POCO 10.0% vs. 12.0% in FFR or IVUS-guided strategy, respectively * Statistical power (1- β): 90% * Primary statistical method : Kaplan-Meier survival analysis with log-rank test * Potential withdrawal rates : total 2% * Stratification in Randomization: Presence of Diabetes Mellitus (600 patients (35%) will be Diabetic patients, with 300 patients in each group) Based on the above assumption, 1,700 patients (850 patients in each group) will be enrolled in this study with consideration of withdrawal rates. 3. Research Materials and Indication for Revascularization For the FFR-guided strategy arm, a pressure-sensor wire system will be used and the criterion for revascularization is FFR ≤ 0.80. Hyperemia will be induced by intravenous infusion of adenosine (140ug/kg/min). For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or \[3mm2 \< MLA ≤ 4mm2 and plaque burden \> 70%\]. 4. Funding This is an investigator-initiated study with grant support from Boston Scientific. Other than financial sponsorship, the company has no role in protocol development or the implementation, management, data collection, and analysis of this study. 5. Extended Outcome Follow-Up Following the 2-year follow-up period, clinical outcomes will also be collected until September 30, 2024, to assess the long-term outcomes of each treatment group.

Conditions

• Stable Angina

Interventions

Type	Name	Description
PROCEDURE	FFR-guided stenting	The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the FFR-guided strategy arm \* Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI
PROCEDURE	IVUS-guided stenting	The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm \* Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 AND Plaque burden \>70%)

Timeline

• Start date: 2016-06-01
• Primary completion: 2025-02-01
• Completion: 2025-12-01
• First posted: 2016-02-03
• Last updated: 2025-02-10

Locations

5 sites across 2 countries: China, South Korea