The Flash FFR Ⅱ Study

NCT04575207 | Unknown DMC

• 1 other identifier: SZRMD2020001
• Study Type: interventional
• Target: 2,132
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• MACE

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

  1 year

Secondary Outcomes (9)

• MACE（excluding PCI-related MI）

  1 month, 1 year, 2 years

• Death

  1 month, 6 months, 1 year, 2 years

• MI

  1 month, 6 months, 1 year, 2 years

• Target vessel revascularization (TVR)

  1 month, 6 months, 1 year, 2 years

• Any coronary artery revascularization

  1 month, 6 months, 1 year, 2 years

Study Arms (2)

caFFR-guided

EXPERIMENTAL

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

FFR-guided

ACTIVE COMPARATOR

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

Interventions

caFFR DIAGNOSTIC_TEST

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.

Also known as: Coronary Angiography-Derived Fractional Flow Reserve

caFFR-guided

FFR DIAGNOSTIC_TEST

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.

Also known as: Fractional Flow Reserve

FFR-guided

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Peking University First Hospital: lead
• Rainmed Ltd., Suzhou, China: collaborator

Study Sites (13)

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

COMPLETED

The University of Hong Kong Shenzhen hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

The People's Hospital of Hebi

Hebi, Henan, 458000, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453100, China

RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330000, China

RECRUITING

QILU Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Affiliated Hospital of Yunnan University

Kunming, Yunnan, 650021, China

RECRUITING

Department of Cardiology, Peking University First Hospital

Beijing, 100034, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 31693092 BACKGROUND

• 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.

  PMID: 19144937 BACKGROUND

• 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.

  PMID: 22924638 BACKGROUND

• 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.

  PMID: 28317458 BACKGROUND

• 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.

  PMID: 28317438 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Angina, Stable; Angina, Unstable; photopsia

Interventions

Fractional Flow Reserve, Myocardial

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coronary Circulation; Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Yong Huo, MD

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Yanjun Gong, MD

CONTACT

8610-83575607; gongyanjun111@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the Flash FFR II study, clinical outcome assessors (including the follow-up research personnel, clinical events committee (CEC), data and safety monitoring board (DSMB), and core laboratory) will be blinded to randomization arm. The data safety monitoring board (DSMB) may request unblinding of grouping information due to patient safety reasons. All the study site personnel will receive training for the blinding requirements before the trial initiating to prevent disclosure of random assignment to the follow-up personnel in any unplanned way.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of cardiology Department

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 5, 2020
• Study Start: January 12, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)