The Flash FFR Ⅱ Study

Last updated: March 20, 2023
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Chest Pain

Angina

Treatment

N/A

Clinical Study ID

NCT04575207
SZRMD2020001
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beperformed if necessary;
  3. Suspected coronary heart disease, stable angina pectoris, unstable anginapectoris, non-culprit vascular assessment in participants with acutenon-ST-segment elevation myocardial infarction, and non-culprit vascularassessment in patients with previous ST-segment elevation acute myocardialinfarction;
  4. Participants voluntarily participate in this clinical trial and sign informedconsent 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, andconsider that PCI surgery is technically feasible.

Exclusion

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 adenosineadministration;
  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 withinthe past 1 month);
  10. The investigator believes that the particitant has other conditions that are notsuitable 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 coronarybranches of extreme vessel foreshortening.

Study Design

Total Participants: 2132
Study Start date:
January 12, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Peking, Beijing 100000
    China

    Active - Recruiting

  • Peking University People's Hospital

    Peking, Beijing 100044
    China

    Active - Recruiting

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian 361000
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510000
    China

    Completed

  • The University of Hong Kong Shenzhen hospital

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

  • The People's Hospital of Hebi

    Hebi, Henan 458000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan 453100
    China

    Active - Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 330000
    China

    Active - Recruiting

  • QILU Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • Affiliated Hospital of Yunnan University

    Kunming, Yunnan 650021
    China

    Active - Recruiting

  • Department of Cardiology, Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

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