The Flash FFR Ⅱ Study

March 20, 2023 updated by: Yong Huo, Peking University First Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100034
        • Recruiting
        • Department of Cardiology, Peking University First Hospital
        • Contact:
        • Sub-Investigator:
          • Yanjun Gong, MD
    • Beijing
      • Peking, Beijing, China, 100000
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
        • Contact:
          • Hongxiu Liu, MD
        • Principal Investigator:
          • Hongxiu Liu, MD
      • Peking, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Yahui Lu, MD
        • Contact:
        • Principal Investigator:
          • Jian Liu, MD
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Xiamen Cardiovascular Hospital Xiamen University
        • Contact:
          • Suiji Li, MD
        • Principal Investigator:
          • Yan Wang, MD
        • Sub-Investigator:
          • Suiji Li, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Completed
        • Guangdong Provincial People's Hospital
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • The University of Hong Kong Shenzhen hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kaihang Yiu, MD
        • Sub-Investigator:
          • Gaozhen Cao, MD
        • Sub-Investigator:
          • Cong Chen, MD
    • Henan
      • Hebi, Henan, China, 458000
        • Recruiting
        • The People's Hospital of Hebi
        • Principal Investigator:
          • Peng Liu, MD
        • Contact:
          • Xueliang Gao, MD
        • Contact:
        • Sub-Investigator:
          • Xueliang Gao, MD
      • Xinxiang, Henan, China, 453100
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
        • Principal Investigator:
          • Guoan Zhao, MD
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Hongmin Zhu, MD
        • Principal Investigator:
          • Lang Hong, MD
        • Sub-Investigator:
          • Hongmin Zhu, MD
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Jianmin Yang, MD
        • Principal Investigator:
          • Jianmin Yang, MD
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Contact:
        • Sub-Investigator:
          • Chenguang Li, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Principal Investigator:
          • Chen Li, MD
    • Yunnan
      • Kunming, Yunnan, China, 650021
        • Recruiting
        • Affiliated Hospital of Yunnan University
        • Contact:
        • Principal Investigator:
          • Xinjin Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: caFFR-guided
Participants who are randomly assigned to caFFR-guided group will receive the detection of Coronary Angiography-Derived Fractional Flow Reserve (caFFR) Measurement System. The online caFFR value is used to guide the PCI strategy. If caFFR ≤ 0.80, PCI treatment will be performed in lesions and optimal medicine treatment will be performed when caFFR > 0.80.
Diagnostic test: caFFR
caFFR is a new index of physiological assessment of coronary artery stenosis severity, based on angiographic images. Through two-dimensional analysis and three-dimensional reconstruction of two coronary angiography image series with an angle-off > 30 degrees, combined with fluid mechanics, TIMI frame counting method, and optimized CFD algorithm, the pressure drop from coronary ostium to every point in the vessel can be obtained, and then the caFFR value of each point in the vessel can be computed. The cutoff value in this trial is caFFR ≤ 0.80 for myocardial ischemia.
Other Names:
  • Coronary Angiography-Derived Fractional Flow Reserve
Active Comparator: FFR-guided
Participants who are randomly assigned to FFR-guided group will receive the detection of pressure wire. The FFR value is used to guide the PCI strategy. If FFR ≤ 0.80, PCI treatment will be performed in lesions and optimal medicine treatment will be performed when FFR > 0.80.
Diagnostic test: FFR
FFR is a widely used, pressure-based functional assessment index of coronary stenoses obtained with an intracoronary pressure wire fitted with pressure sensors. The pressure wire passes through the stenosis and directly measures the pressure distal to the stenosis. FFR value can be obtained by combining the pressure at the coronary ostium and the distal pressure to the stenosis. The cutoff value in this trial is FFR ≤ 0.80 for myocardial ischemia.
Other Names:
  • Fractional Flow Reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 1 year
A composite of all-cause death, myocardial infarction (MI), and unplanned revascularization
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE（excluding PCI-related MI）
Time Frame: 1 month, 1 year, 2 years
A composite of all-cause death, myocardial infarction (excluding PCI-related), and unplanned revascularization
1 month, 1 year, 2 years
Death
Time Frame: 1 month, 6 months, 1 year, 2 years
Cardiovascular, non-cardiovascular, and undetermined death
1 month, 6 months, 1 year, 2 years
MI
Time Frame: 1 month, 6 months, 1 year, 2 years
Target vessel related and non-target vessel related MI
1 month, 6 months, 1 year, 2 years
Target vessel revascularization (TVR)
Time Frame: 1 month, 6 months, 1 year, 2 years
The ischemia driven and non-ischemia driven TVR
1 month, 6 months, 1 year, 2 years
Any coronary artery revascularization
Time Frame: 1 month, 6 months, 1 year, 2 years
The ischemia driven and non-ischemia driven revascularization
1 month, 6 months, 1 year, 2 years
Definite or probable stent thrombosis
Time Frame: 1 month, 6 months, 1 year, 2 years
Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase
1 month, 6 months, 1 year, 2 years
Evaluation of health economics
Time Frame: 1 month, 6 months, 1 year
Cost-utility analysis and computation of incremental cost-effectiveness ratio.
1 month, 6 months, 1 year
Analysis of participant discomfort during the operation (none/mild/moderate/severe )
Time Frame: During the operation
During the caFFR or FFR detection, the operator will ask the participant if there is discomfort (none/mild/moderate/severe ) and what kind of discomfort(such as palpitation, chest stuffy , nausea, dizziness, foreign body invasion ), and fill out a questionnaire after the operation.The discomfort of all participants caused by the use of drugs, intervention, etc. during the caFFR or FFR detection will be analyzed.
During the operation
The changes of PCI strategy depending on caFFR/FFR information
Time Frame: During the operation

Before randomization,the operators will be asked to provide their planned treatment strategy based on the angiographic information alone.

After randomization and functional assessment,we will record how caFFR/FFR changed the treatment strategy.
During the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Rainmed Ltd., Suzhou, China

Investigators

  • Study Chair: Yong Huo, MD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZRMD2020001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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