FFR Versus IVUS With Angiography-Derived FFR for Clinical Outcomes in Patients With Coronary Artery Disease

NCT06218485 | Active Not Recruiting DMC

• 1 other identifier: 2023-0896
• Study Type: interventional
• Target: 1,942
• Locations: 2 countries
• Sites: 32

Brief Summary

To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.

Conditions

Coronary Artery Disease

Keywords

Angiography-derived fractional flow reserve; Intravascular ultrasound; Fractional flow reserve; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Patient-oriented composite outcome

  Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI), or any revascularization at 24 months after randomization.

  24 months

Secondary Outcomes (11)

• Patient-oriented composite outcome at 60 months

  60 months

• Individual component of Patient-oriented composite outcome

  24 and 60 months

• Target vessel failure

  24 and 60 months

• All-cause and cardiac death

  24 and 60 months

• Any nonfatal myocardial infarction without peri-procedural myocardial infarction

  24 and 60 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making.

Procedure: Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making

Control group

ACTIVE COMPARATOR

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy.

Procedure: Fractional flow reserve-guided PCI strategy

Interventions

Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making PROCEDURE

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making: 1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80. 2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area

Experimental group

Fractional flow reserve-guided PCI strategy PROCEDURE

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy: 1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80. 2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05

Control group

Eligibility Criteria

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

You may qualify if:

• Subject must be ≥ 19 years.
• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent.
• Subjects suspected with ischemic heart disease.
• Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation.
• Target vessel size ≥ 2.5mm in visual estimation.

You may not qualify if:

• Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor
• Active pathologic bleeding.
• Gastrointestinal or genitourinary major bleeding within the prior 3 months.
• History of bleeding diathesis, known coagulopathy.
• Non-cardiac co-morbid conditions with life expectancy \< 2 years.
• Target lesion located in coronary arterial bypass graft.
• Left main coronary artery stenosis ≥ 50%.
• Chronic total occlusion in the study target vessel.
• Culprit lesion of ST-elevation myocardial infarction (STEMI).
• Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, severe tortuosity, severe overlap, poor image quality).

Sponsors & Collaborators

• Seoul National University Hospital: collaborator
• Peking University Third Hospital: collaborator
• Second Affiliated Hospital of Shantou University Medical College: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• The Fourth People's Hospital of Jinan: collaborator
• Jinhua Central Hospital: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• Changxing People's Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The Affiliated Hospital of Medical College, Ningbo University: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Inje University Ilsan Paik Hospital: collaborator
• Ulsan University Hospital: collaborator
• Inje University Haeundae Paik Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead
• Uijeongbu Eulji University Hospital: collaborator
• Jining First People's Hospital: collaborator
• Huzhou Central Hospital: collaborator
• Zhejiang Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• Wuhan Aisa Heart Hospital: collaborator
• The Southwest Hospital of Army Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Ganzhou People's Hospital, Jiangxi Province: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Shanxi Cardiovascular Hosipital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Sites (32)

Peking University Third Hospital

Beijing, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

The Southwest Hospital of Army Medical University

Chongqing, China

Location

Ganzhou People's Hospital

Ganzhou, China

Location

Second Affiliated Hospital of Shantou University Medical College

Guangdong, China

Location

Hangzhou First People's Hospital

Hangzhou, China

Location

Sir Run Run Shaw Hospital

Hangzhou, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Zhejiang Hospital

Hangzhou, China

Location

Changxing People's Hospital

Huzhou, China

Location

Huzhou Central Hospital

Huzhou, China

Location

The Fourth People's Hospital of Jinan

Jinan, China

Location

Jinhua Central Hospital

Jinhua, China

Location

Jining No.1 People's Hospital

Jining, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Location

The Affiliated Hospital of Medical College, Ningbo University

Ningbo, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, China

Location

The First Affiliated hospital of Wenzhou Medical University

Wenzhou, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

Wuhan Aisa Heart Hospital

Wuhan, China

Location

The Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, China

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chonnam National University Hospital

Donggu, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Seoul National University Hospital,

Seoul, South Korea

Location

Uijeongbu Eulji Medical Center

Uijeongbu-si, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Related Publications (10)

• Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285.

  PMID: 29790954 BACKGROUND

• De Maria GL, Garcia-Garcia HM, Scarsini R, Hideo-Kajita A, Gonzalo Lopez N, Leone AM, Sarno G, Daemen J, Shlofmitz E, Jeremias A, Tebaldi M, Bezerra HG, Tu S, Lemos PA, Ozaki Y, Dan K, Collet C, Banning AP, Barbato E, Johnson NP, Waksman R. Novel Indices of Coronary Physiology: Do We Need Alternatives to Fractional Flow Reserve? Circ Cardiovasc Interv. 2020 Apr;13(4):e008487. doi: 10.1161/CIRCINTERVENTIONS.119.008487. Epub 2020 Apr 16.

  PMID: 32295416 BACKGROUND

• Scoccia A, Tomaniak M, Neleman T, Groenland FTW, Plantes ACZD, Daemen J. Angiography-Based Fractional Flow Reserve: State of the Art. Curr Cardiol Rep. 2022 Jun;24(6):667-678. doi: 10.1007/s11886-022-01687-4. Epub 2022 Apr 18.

  PMID: 35435570 BACKGROUND

• Collet C, Onuma Y, Sonck J, Asano T, Vandeloo B, Kornowski R, Tu S, Westra J, Holm NR, Xu B, de Winter RJ, Tijssen JG, Miyazaki Y, Katagiri Y, Tenekecioglu E, Modolo R, Chichareon P, Cosyns B, Schoors D, Roosens B, Lochy S, Argacha JF, van Rosendael A, Bax J, Reiber JHC, Escaned J, De Bruyne B, Wijns W, Serruys PW. Diagnostic performance of angiography-derived fractional flow reserve: a systematic review and Bayesian meta-analysis. Eur Heart J. 2018 Sep 14;39(35):3314-3321. doi: 10.1093/eurheartj/ehy445.

  PMID: 30137305 BACKGROUND

• Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.

  PMID: 30586699 BACKGROUND

• Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

  PMID: 29101020 BACKGROUND

• Koo BK, Hu X, Kang J, Zhang J, Jiang J, Hahn JY, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Ahn SG, Yoon MH, Kim U, Lee JM, Hwang D, Ki YJ, Shin ES, Kim HS, Tahk SJ, Wang J; FLAVOUR Investigators. Fractional Flow Reserve or Intravascular Ultrasonography to Guide PCI. N Engl J Med. 2022 Sep 1;387(9):779-789. doi: 10.1056/NEJMoa2201546.

  PMID: 36053504 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

• Kogame N, Ono M, Kawashima H, Tomaniak M, Hara H, Leipsic J, Andreini D, Collet C, Patel MR, Tu S, Xu B, Bourantas CV, Lerman A, Piek JJ, Davies JE, Escaned J, Wijns W, Onuma Y, Serruys PW. The Impact of Coronary Physiology on Contemporary Clinical Decision Making. JACC Cardiovasc Interv. 2020 Jul 27;13(14):1617-1638. doi: 10.1016/j.jcin.2020.04.040.

  PMID: 32703589 RESULT

• Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9.

  PMID: 34895950 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jian'an Wang, MD, PhD

  Second Affiliated Hospital, Zhejiang University, School of Medicine

  PRINCIPAL INVESTIGATOR

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 23, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2031
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Requestors will be required to sign a Data Access Agreement

Locations

CN (25); KR (7)