A Prospective, Multicenter, Blinded, Randomized, Noninferiority Clinical Trial of Coronary Angiography Fractional Flow Reserve (caFFR) Versus Fractional Flow Reserve (FFR) to Guide Percutaneous Coronary Intervention(Flash FFR Ⅱ )
The overall purpose of Flash FFR Ⅱ is to investigate whether coronary angiography-derived fractional flow reserve (caFFR), compared with fractional flow reserve (FFR) measured by a pressure wire, has non-inferior clinical effect and cost benefit in guiding the percutaneous coronary intervention (PCI) for patients with moderate coronary artery stenosis in terms of long-term clinical prognosis.
• General inclusion criteria:
∙ Age above 18 years old, no limit on the gender;
‣ Angiography is considered necessary and feasible by investigator, and PCI will be performed if necessary;
‣ Suspected coronary heart disease, stable angina pectoris, unstable angina pectoris, non-culprit vascular assessment in participants with acute non-ST-segment elevation myocardial infarction, and non-culprit vascular assessment in patients with previous ST-segment elevation acute myocardial infarction;
‣ Participants voluntarily participate in this clinical trial and sign informed consent form.
• Coronary angiography inclusion criteria:
• The presence of at least one stenosis and meets the following imaging findings:
⁃ The degree of coronary artery stenosis≥50% and ≤90% by visual measurement;
⁃ The reference diameter of the stenotic segment≥2.25 mm by visual measurement;
⁃ The investigator visually observes the target vessel through angiographic images, and consider that PCI surgery is technically feasible.