The Flash FFR Ⅱ Study

  • STATUS
    Recruiting
  • End date
    Jun 24, 2024
  • participants needed
    2132
  • sponsor
    Peking University First Hospital
Updated on 24 March 2022
angiography
stenosis
heart disease
myocardial infarction
angina pectoris
unstable angina
infarct
ischemia
coronary artery stenosis
stable angina

Summary

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.

Description

Flash FFR Ⅱ is a prospective, multicenter, blinded, randomized, non-inferiority trial. Eligible patients with moderate coronary artery stenosis will be included in the study and randomly assigned to either caFFR-guided group or FFR-guided group. Participant caFFR or FFR will be used to guide percutaneous coronary intervention (PCI) strategy.

The rate of major cardiovascular adverse events (MACE) and the cost data will be collected during the long-term follow-up (2 years). MACE is defined as a composite of all-cause death, myocardial infarction (MI), unplanned revascularization. Clinical outcomes and cost-effectiveness will be compared between the two groups.

A subgroup analysis is pre-set and included in the protocol, including age, sex, body mass index, diabetes mellitus, smoking status, mean aortic pressure (resting state), acute coronary syndrome, left ventricular ejection fraction, lesion site, lesion stenosis severity, target vessel reference diameter, small vessel lesion, blood flow velocity, PCI mode, and so on.

The trial is equipped with a core laboratory. Some interesting sub-studies will be carried out, such as a comparison of laboratory and operator analysis results.

If the trial results show non-inferiority, it should be noted that caFFR can bring new benefits to both operators and patients as a new index of physiological assessment of coronary artery stenosis severity with the advantages of lower cost, less risk, faster time, and less use of resources.

Details
Condition Coronary Artery Disease, Coronary Stenosis, Myocardial Ischaemia, Coronary Circulation, Stable Angina Pectoris, Unstable Angina Pectoris, Asymptomatic Ischemia, Acute Myocardial Infarction, Percutaneous Coronary Intervention
Treatment FFR, caFFR
Clinical Study IdentifierNCT04575207
SponsorPeking University First Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

General 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
Severe aortic stenosis
Life expectancy less than 1 year
Pregnant women or women planning a recent pregnancy
Participation in any other clinical trials of devices or drugs (ongoing or within the past 1 month)
The investigator believes that the particitant has other conditions that are not suitable for clinical trials
Coronary angiography exclusion criteria
TIMI flow in the target vessel<grade III
Presence of myocardial bridge and systolic compression ≥50% in the target vessel
Presence of artificial bypass in the target vessel
Left main coronary artery or right coronary artery ostial lesions
Stent implantation in the target vessel within 3 months
Target vessel provides collateral support to chronically total occluded vessels
Presence of factors affecting angiographic analysis and stenosis visualization, including incomplete vessel opacification, or overlap with other coronary branches of extreme vessel foreshortening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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