Clinical trial NCT04575207: The Flash FFR Ⅱ Study
Official title: 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 ）
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Stenosis
Myocardial Ischaemia
Coronary Circulation
Stable Angina Pectoris
Unstable Angina Pectoris
Asymptomatic Ischemia
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Keywords: Flash
FFR
caFFR
coronary angiography-derived fractional flow reserve
Coronary Artery Disease
Myocardial Ischaemia
Percutaneous Coronary Intervention
Coronary Circulation
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Rainmed Ltd., Suzhou, China
First posted: 2020-10-05
Enrollment: 2132
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* General inclusion criteria:

  1. Age above 18 years old, no limit on the gender;
  2. Angiography is considered necessary and feasible by investigator, and PCI will be performed if necessary;
  3. 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;
  4. 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:

1. The degree of coronary artery stenosis≥50% and ≤90% by visual measurement;
2. The reference diameter of the stenotic segment≥2.25 mm by visual measurement;
3. The investigator visually observes the target vessel through angiographic images, and consider that PCI surgery is technically feasible.

Exclusion Criteria:

* General exclusion criteria:

  1. Acute ST-segment elevation myocardial infarction within 6 days;
  2. Cardiogenic shock or left ventricular ejection fraction≤50%;
  3. eGFR \< 30 mL/min (1.73 m2);
  4. Severe coagulation dysfunctions or bleeding disorders;
  5. Allergic to iodine contrast medium or contraindications for adenosine administration;
  6. Severe aortic stenosis;
  7. Life expectancy less than 1 year;
  8. Pregnant women or women planning a recent pregnancy;
  9. Participation in any other clinical trials of devices or drugs (ongoing or within the past 1 month);
  10. The investigator believes that the particitant has other conditions that are not suitable for clinical trials.
* Coronary angiography exclusion criteria:

  1. TIMI flow in the target vessel\<grade III ;
  2. Presence of myocardial bridge and systolic compression ≥50% in the target vessel;
  3. Presence of artificial bypass in the target vessel;
  4. Left main coronary artery or right coronary artery ostial lesions;
  5. Stent implantation in the target vessel within 3 months;
  6. Target vessel provides collateral support to chronically total occluded vessels;
  7. Presence of factors affecting angiographic analysis and stenosis visualization, including incomplete vessel opacification, or overlap with other coronary branches of extreme vessel foreshortening.

Primary outcomes:
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: MACE（excluding PCI-related MI）
timeFrame: 1 month, 1 year, 2 years
measure: Death
timeFrame: 1 month, 6 months, 1 year, 2 years
measure: MI
timeFrame: 1 month, 6 months, 1 year, 2 years
measure: Target vessel revascularization (TVR)
timeFrame: 1 month, 6 months, 1 year, 2 years
measure: Any coronary artery revascularization
timeFrame: 1 month, 6 months, 1 year, 2 years
measure: Definite or probable stent thrombosis
timeFrame: 1 month, 6 months, 1 year, 2 years
measure: Evaluation of health economics
timeFrame: 1 month, 6 months, 1 year
measure: Analysis of participant discomfort during the operation (none/mild/moderate/severe )
timeFrame: During the operation
measure: The changes of PCI strategy depending on caFFR/FFR information
timeFrame: During the operation
Other outcomes:
Locations:
city: Peking
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Cardiovascular Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong Shenzhen hospital
state: Guangdong
city: Hebi
country: China
facility: The People's Hospital of Hebi
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
state: Henan
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Jinan
country: China
facility: QILU Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: Affiliated Hospital of Yunnan University
state: Yunnan
city: Beijing
country: China
facility: Department of Cardiology, Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, MD
role: STUDY_CHAIR
References:
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citation: Gotberg M, Christiansen EH, Gudmundsdottir IJ, Sandhall L, Danielewicz M, Jakobsen L, Olsson SE, Ohagen P, Olsson H, Omerovic E, Calais F, Lindroos P, Maeng M, Todt T, Venetsanos D, James SK, Karegren A, Nilsson M, Carlsson J, Hauer D, Jensen J, Karlsson AC, Panayi G, Erlinge D, Frobert O; iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823. doi: 10.1056/NEJMoa1616540. Epub 2017 Mar 18.