Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2132 participants
INTERVENTIONAL
2021-01-12
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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.
19 Years
ALL
No
Sponsors
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Rainmed Ltd., Suzhou, China
UNKNOWN
Peking University First Hospital
OTHER
Responsible Party
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Yong Huo
Chief physician of cardiology Department
Principal Investigators
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Yong Huo, MD
Role: STUDY_CHAIR
Peking University First Hospital
Locations
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Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The University of Hong Kong Shenzhen hospital
Shenzhen, Guangdong, China
The People's Hospital of Hebi
Hebi, Henan, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
QILU Hospital of Shandong University
Jinan, Shandong, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
Department of Cardiology, Peking University First Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Hongxiu Liu, MD
Role: primary
Yahui Lu, MD
Role: primary
Suiji Li, MD
Role: primary
Xueliang Gao, MD
Role: primary
Hongmin Zhu, MD
Role: primary
Jianmin Yang, MD
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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SZRMD2020001
Identifier Type: -
Identifier Source: org_study_id
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