The Flash FFR â…¡ Study (NCT04575207) | Clinical Trial Compass
UnknownNot Applicable
The Flash FFR â…¡ Study
China2,132 participantsStarted 2021-01-12
Plain-language summary
The overall purpose of Flash FFR â…¡ 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.
Who can participate
Age range19 Years
SexALL
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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.
✓. 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.
Exclusion criteria
✕. Acute ST-segment elevation myocardial infarction within 6 days;
✕. Cardiogenic shock or left ventricular ejection fraction≤50%;
✕. eGFR \< 30 mL/min (1.73 m2);
✕. Severe coagulation dysfunctions or bleeding disorders;
✕. Allergic to iodine contrast medium or contraindications for adenosine administration;