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The Flash FFR Ⅱ Study

Primary Purpose

Coronary Artery Disease, Coronary Stenosis, Myocardial Ischaemia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

caFFR

FFR

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Flash, FFR, caFFR, coronary angiography-derived fractional flow reserve, Coronary Artery Disease, Myocardial Ischaemia, Percutaneous Coronary Intervention, Coronary Circulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

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.

Sites / Locations

Beijing Hospital of Traditional Chinese Medicine, Capital Medical UniversityRecruiting
Peking University People's HospitalRecruiting
Xiamen Cardiovascular Hospital Xiamen UniversityRecruiting
Guangdong Provincial People's Hospital
The University of Hong Kong Shenzhen hospitalRecruiting
The People's Hospital of HebiRecruiting
The First Affiliated Hospital of Xinxiang Medical CollegeRecruiting
Jiangxi Provincial People's HospitalRecruiting
QILU Hospital of Shandong UniversityRecruiting
Zhongshan Hospital affiliated to Fudan UniversityRecruiting
West China Hospital, Sichuan UniversityRecruiting
Affiliated Hospital of Yunnan UniversityRecruiting
Department of Cardiology, Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

caFFR-guided

FFR-guided

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

MACE

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

Secondary Outcome Measures

MACE（excluding PCI-related MI）

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

Death

Cardiovascular, non-cardiovascular, and undetermined death

Target vessel related and non-target vessel related MI

Target vessel revascularization (TVR)

The ischemia driven and non-ischemia driven TVR

Any coronary artery revascularization

The ischemia driven and non-ischemia driven revascularization

Definite or probable stent thrombosis

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

Evaluation of health economics

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

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.

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.

Full Information

NCT ID

NCT04575207

First Posted

September 22, 2020

Last Updated

March 20, 2023

Sponsor

Peking University First Hospital

Collaborators

Rainmed Ltd., Suzhou, China

1. Study Identification

Unique Protocol Identification Number

NCT04575207

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 12, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University First Hospital

Collaborators

Rainmed Ltd., Suzhou, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

2132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

caFFR-guided

Arm Type

Experimental

Arm Description

Arm Title

FFR-guided

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

caFFR

Other Intervention Name(s)

Coronary Angiography-Derived Fractional Flow Reserve

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

FFR

Other Intervention Name(s)

Fractional Flow Reserve

Intervention Description

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.

Primary Outcome Measure Information:

Title

MACE

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

MACE（excluding PCI-related MI）

Description

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

Time Frame

1 month, 1 year, 2 years

Title

Death

Description

Cardiovascular, non-cardiovascular, and undetermined death

Time Frame

1 month, 6 months, 1 year, 2 years

Title

Description

Target vessel related and non-target vessel related MI

Time Frame

1 month, 6 months, 1 year, 2 years

Title

Target vessel revascularization (TVR)

Description

The ischemia driven and non-ischemia driven TVR

Time Frame

1 month, 6 months, 1 year, 2 years

Title

Any coronary artery revascularization

Description

The ischemia driven and non-ischemia driven revascularization

Time Frame

1 month, 6 months, 1 year, 2 years

Title

Definite or probable stent thrombosis

Description

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

Time Frame

1 month, 6 months, 1 year, 2 years

Title

Evaluation of health economics

Description

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

Time Frame

1 month, 6 months, 1 year

Title

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

Description

Time Frame

During the operation

Title

The changes of PCI strategy depending on caFFR/FFR information

Description

Time Frame

During the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: 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. Exclusion Criteria: 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanjun Gong, MD

Phone

8610-83575607

gongyanjun111@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong Huo, MD

Organizational Affiliation

Peking University First Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

City

Peking

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongxiu Liu, MD

First Name & Middle Initial & Last Name & Degree

Hongxiu Liu, MD

Facility Name

Peking University People's Hospital

City

Peking

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yahui Lu, MD

First Name & Middle Initial & Last Name & Degree

Jian Liu

drjianliu@163.com

First Name & Middle Initial & Last Name & Degree

Jian Liu, MD

Facility Name

Xiamen Cardiovascular Hospital Xiamen University

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suiji Li, MD

First Name & Middle Initial & Last Name & Degree

Yan Wang, MD

First Name & Middle Initial & Last Name & Degree

Suiji Li, MD

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Completed

Facility Name

The University of Hong Kong Shenzhen hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cong Chen, MD

Phone

0086+1866496688

chenc6@hku-szh.org

First Name & Middle Initial & Last Name & Degree

Gaozhen Cao, MD

Phone

0086+18307555105

caogz@hku-szh.org

First Name & Middle Initial & Last Name & Degree

Kaihang Yiu, MD

First Name & Middle Initial & Last Name & Degree

Gaozhen Cao, MD

First Name & Middle Initial & Last Name & Degree

Cong Chen, MD

Facility Name

The People's Hospital of Hebi

City

Hebi

State/Province

Henan

ZIP/Postal Code

458000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xueliang Gao, MD

First Name & Middle Initial & Last Name & Degree

Peng Liu, MD

nick-208@126.com

First Name & Middle Initial & Last Name & Degree

Peng Liu, MD

First Name & Middle Initial & Last Name & Degree

Xueliang Gao, MD

Facility Name

The First Affiliated Hospital of Xinxiang Medical College

City

Xinxiang

State/Province

Henan

ZIP/Postal Code

453100

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guoan Zhao, MD

guoanzhao@xxmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Guoan Zhao, MD

Facility Name

Jiangxi Provincial People's Hospital

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongmin Zhu, MD

First Name & Middle Initial & Last Name & Degree

Lang Hong, MD

First Name & Middle Initial & Last Name & Degree

Hongmin Zhu, MD

Facility Name

QILU Hospital of Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianmin Yang, MD

First Name & Middle Initial & Last Name & Degree

Jianmin Yang, MD

Facility Name

Zhongshan Hospital affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chenguang Li, MD

chenguang.li@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Junbo Ge, MD

First Name & Middle Initial & Last Name & Degree

Chenguang Li, MD

Facility Name

West China Hospital, Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chen Li, MD

69825160@qq.com

First Name & Middle Initial & Last Name & Degree

Chen Li, MD

Facility Name

Affiliated Hospital of Yunnan University

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinjin Zhang, MD

zxjgry2004@sina.com

First Name & Middle Initial & Last Name & Degree

Xinjin Zhang, MD

Facility Name

Department of Cardiology, Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanjun Gong, MD

Phone

8610-83575607

gongyanjun111@163.com

First Name & Middle Initial & Last Name & Degree

Yong Huo, MD

First Name & Middle Initial & Last Name & Degree

Yanjun Gong, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31693092

Citation

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.

Results Reference

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PubMed Identifier

19144937

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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Citation

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.

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Citation

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The Flash FFR Ⅱ Study

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