Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With Coronary Artery Disease (FLAVOUR II)

Zhejiang University

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Procedure: IVUS; Procedure: Angiography-derived FFR

Study type: Interventional

Funder types: Other

Identifiers

NCT04397211

2019-303

Details and patient eligibility

About

Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with CoRonary Artery Disease

Full description

1. The primary hypothesis is that angiography-derived FFR-guided strategy for PCI with a drug-eluting stent (DES) will show non-inferiority in rates of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with coronary artery disease.

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 12 months after PCI will be 7% in the Angiography-derived FFR-guided arm, and 8% in the IVUS-guided arm

   • Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any revascularization) at 12 months after PCI
   • Design: non-inferiority, delta = 2.5%
   • Sampling ratio: angiography-derived FFR-guided strategy: IVUS-guided strategy = 1:1
   • Type I error (α): One-sided 2.5%
   • Accrual time: 3 years
   • Total time: 4 years (accrual 3 years + follow-up 1 years)
   • Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
   • Statistical power (1- β): 80%
   • Primary statistical method: Kaplan-Meier survival analysis with log-rank test
   • Estimated attrition rate: total 5%
   • Stratification in Randomization: Presence of diabetes mellitus (35% of patients in each group) Based on the above assumption, we would need total 1,872 patients (936 patients in each group) with consideration of an attrition rate.

3. Research Materials and Indication for Revascularization： For the angiography-derived FFR-guided strategy arm, criteria for revascularization: angiography-derived FFR ≤ 0.80. For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or [3mm2 < MLA ≤ 4mm2 and plaque burden > 70%].

Enrollment: 1,872 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ① Subject must be ≥ 18 years. ② Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. ③ Patients suspected with ischemic heart disease. ④ Patients with ≥ 50% stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])

Exclusion criteria

• ① The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.) ② Patients with active pathologic bleeding. ③ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ④ History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,872 participants in 2 patient groups

Angiography-derived FFR-guided PCI group

Active Comparator group

Description:

Percutaneous coronary intervention using drug-eluting stent(s) will be performed by Angiography-derived FFR-guided strategy

Treatment:

Procedure: Angiography-derived FFR

IVUS-guided PCI group

Active Comparator group

Description:

Percutaneous coronary intervention using drug-eluting stent(s) will be performed by IVUS-guided strategy

Treatment:

Procedure: IVUS