Angiography-Derived FFR And IVUS for Clinical Outcomes in Patients With

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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%]. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04397211
Study type	Interventional
Source	Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 29, 2020
Completion date	September 2028

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms