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Coronary Artery DiseaseNCT04575207

The Flash FFR Ⅱ Study

A study testing caFFR and FFR in people with Coronary Artery Disease and Coronary Stenosis, run by Peking University First Hospital at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
caFFR and FFR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,132 participants
Where
13 sitesChina
Study dates
12 Jan 2021to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country.

Yanjun Gong, MD contact

8610-83575607

gongyanjun111@163.com

13 sites in 1 country

China13 sites, 12 recruiting

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Beijing, Beijing Municipality, 100000

    Hongxiu Liu, MD

    Hongxiu Liu, MD

    Recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Yahui Lu, MD

    Jian Liu, drjianliu@163.com

    Recruiting

  • Department of Cardiology, Peking University First Hospital

    Beijing, 100034

    Yanjun Gong, MD, 8610-83575607, gongyanjun111@163.com

    Yong Huo, MD

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

    Chen Li, MD, 69825160@qq.com

    Chen Li, MD

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Completed

  • The People's Hospital of Hebi

    Hebi, Henan, 458000

    Xueliang Gao, MD

    Peng Liu, MD, nick-208@126.com

    Recruiting

  • QILU Hospital of Shandong University

    Jinan, Shandong, 250012

    Jianmin Yang, MD

    Jianmin Yang, MD

    Recruiting

  • Affiliated Hospital of Yunnan University

    Kunming, Yunnan, 650021

    Xinjin Zhang, MD, zxjgry2004@sina.com

    Xinjin Zhang, MD

    Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330000

    Hongmin Zhu, MD

    Lang Hong, MD

    Recruiting

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

    Chenguang Li, MD, chenguang.li@zs-hospital.sh.cn

    Junbo Ge, MD

    Recruiting

  • The University of Hong Kong Shenzhen hospital

    Shenzhen, Guangdong, 518000

    Cong Chen, MD, 0086+1866496688, chenc6@hku-szh.org

    Gaozhen Cao, MD, 0086+18307555105, caogz@hku-szh.org

    Recruiting

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian, 361000

    Suiji Li, MD

    Yan Wang, MD

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan, 453100

    Guoan Zhao, MD, guoanzhao@xxmu.edu.cn

    Guoan Zhao, MD

    Recruiting

Other trials in China

About this 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 ）

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.

Read the 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.

Being tested
caFFR, FFR
Keywords
Flash, FFR, caFFR, coronary angiography-derived fractional flow reserve, Coronary Artery Disease, Myocardial Ischaemia, Percutaneous Coronary Intervention, Coronary Circulation
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, Angina, Stable, Angina, Unstable, photopsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • caFFRDiagnostic test

    Also called Coronary Angiography-Derived Fractional Flow Reserve

    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.

  • FFRDiagnostic test

    Also called Fractional Flow Reserve

    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.

Study groups in NCT04575207
Study groupRoleWhat they receive
caFFR-guidedExperimentalParticipants 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.
Receives: Diagnostic Test: caFFR
FFR-guidedActive comparatorParticipants 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.
Receives: Diagnostic Test: FFR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

    A composite of all-cause death, myocardial infarction (MI), and unplanned revascularization

    Measured: 1 year

Secondary outcomes (9)

  1. MACE（excluding PCI-related MI）

    A composite of all-cause death, myocardial infarction (excluding PCI-related), and unplanned revascularization

    Measured: 1 month, 1 year, 2 years

  2. Death

    Cardiovascular, non-cardiovascular, and undetermined death

    Measured: 1 month, 6 months, 1 year, 2 years

  3. MI

    Target vessel related and non-target vessel related MI

    Measured: 1 month, 6 months, 1 year, 2 years

  4. Target vessel revascularization (TVR)

    The ischemia driven and non-ischemia driven TVR

    Measured: 1 month, 6 months, 1 year, 2 years

  5. Any coronary artery revascularization

    The ischemia driven and non-ischemia driven revascularization

    Measured: 1 month, 6 months, 1 year, 2 years

  6. Definite or probable stent thrombosis

    Definite and probable stent thrombosis during acute, sub-acute, late, and very late phase

    Measured: 1 month, 6 months, 1 year, 2 years

  7. Evaluation of health economics

    Cost-utility analysis and computation of incremental cost-effectiveness ratio.

    Measured: 1 month, 6 months, 1 year

  8. Analysis of participant discomfort during the operation (none/mild/moderate/severe )

    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.

    Measured: During the operation

  9. The changes of PCI strategy depending on caFFR/FFR information

    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.

    Measured: During the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start12 Jan 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04575207
Sponsor's protocol ID
SZRMD2020001
Status last verified
Mar 2023
First submitted
22 Sep 2020
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li J, Gong Y, Wang W, Yang Q, Liu B, Lu Y, Xu Y, Huo Y, Yi T, Liu J, Li Y, Xu S, Zhao L, Ali ZA, Huo Y. Accuracy of computational pressure-fluid dynamics applied to coronary angiography to derive fractional flow reserve: FLASH FFR. Cardiovasc Res. 2020 Jun 1;116(7):1349-1356. doi: 10.1093/cvr/cvz289.

    PubMed 31693092

  • Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

    PubMed 19144937

  • De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27.

    PubMed 22924638

  • Davies JE, Sen S, Dehbi HM, Al-Lamee R, Petraco R, Nijjer SS, Bhindi R, Lehman SJ, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Harle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Canas Silva P, Baptista SB, Alghamdi A, Hellig F, Koo BK, Nam CW, Shin ES, Doh JH, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J. Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. doi: 10.1056/NEJMoa1700445. Epub 2017 Mar 18.

    PubMed 28317458

  • 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.

    PubMed 28317438

Questions about this trial

What is this clinical trial studying?

A study testing caFFR and FFR in people with Coronary Artery Disease and Coronary Stenosis, run by Peking University First Hospital at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanjun Gong, MD (8610-83575607, gongyanjun111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04575207, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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