The FAVOR III China Study

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Aug 31, 2018

Keywords

ClinConnect Summary

The FAVOR III China is a prospective, multicenter, blinded, randomized, superiority clinical trial comparing the clinical outcome and cost-effectiveness of the two PCI strategies, QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only-guided (angiography-guided) strategy , in evaluation of patients with coronary artery disease (CAD). The study is adequately powered to detect if the primary outcome by the QFR-guided PCI strategy is superior to the standard angiography-guided PCI strategy. The hypothesis is that a QFR-guided PCI strategy results in superior clinical...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• General inclusion criteria:
• • Age ≥ 18 years
• • Stable or unstable angina pectoris, or post-acute myocardial infarction (≥ 72 hrs)
• • Signed written informed consent
• • Eligible for PCI by the operators
• Angiographic inclusion criteria:
• • At least one lesion is present of DS% ≥50% and ≤90% in one major native epicardial coronary artery and supplying viable myocardium
• • Reference lumen diameter ≥ 2.5mm by visual assessment
• Exclusion Criteria:
• General exclusion criteria:
• • Cardiogenic shock or severe heart failure (NYHA ≥III)
• • Severely impaired renal function: creatinine \> 150μmol/L or Cockcroft-Gault calculated GFR \< 45 ml/kg/1.73 m2
• • Allergy to iodine-containing contrast agents
• • Pregnancy or intention to become pregnant during the course of the trial
• • Life expectancy less than one year
• Angiographic exclusion criteria:
• • With only one coronary artery lesion（DS%\>90%）with TIMI flow \< 3
• • Target stenoses are culprit lesions related with acute myocardial infarction
• • Target stenoses in the vessel involving myocardial bridge
• • Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast filling
• • Severe overlap in the stenosed segment or severe tortuosity of any target vessel deemed unable for QFR measurement