Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study
Introduction The previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from i...
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2020-12-01
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| author | Daniele Andreini Kaoru Tanaka Hideyuki Kawashima Ronny R Buechel William Wijns Torsten Doenst Jonathon Leipsic Gregg W Stone Giulio Pompilio Antonio L Bartorelli Saima Mushtaq Enrico Ferrari Francesco Maisano Mark La Meir Johan De Mey Ulrich Schneider Ulf Teichgräber Faisal Sharif Robbert de Winter Brian Thomsen Charles Taylor Campbell Rogers Yoshinobu Onuma Patrick W Serruys |
| author_facet | Daniele Andreini Kaoru Tanaka Hideyuki Kawashima Ronny R Buechel William Wijns Torsten Doenst Jonathon Leipsic Gregg W Stone Giulio Pompilio Antonio L Bartorelli Saima Mushtaq Enrico Ferrari Francesco Maisano Mark La Meir Johan De Mey Ulrich Schneider Ulf Teichgräber Faisal Sharif Robbert de Winter Brian Thomsen Charles Taylor Campbell Rogers Yoshinobu Onuma Patrick W Serruys |
| author_sort | Daniele Andreini |
| collection | DOAJ |
| description | Introduction The previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from invasive coronary angiography (ICA). The study objective of the FASTTRACK CABG is to assess the feasibility of CCTA and fractional flow reserve derived from CTA (FFRCT) to replace ICA as a surgical guidance method for planning and execution of CABG in patients with three-vessel disease with or without left main disease.Methods and analysis The FASTTRACK CABG is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept and first-in-man study with feasibility and safety analysis. Surgical revascularisation strategy and treatment planning will be solely based on CCTA and FFRCT without knowledge of the anatomy defined by ICA. Clinical follow-up visit including CCTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularisation with respect to the surgical planning based on non-invasive imaging (CCTA) with functional assessment (FFRCT) and compared with ICA. Primary feasibility endpoint is CABG planning and execution solely based on CCTA and FFRCT in 114 patients. Primary safety endpoint based on 30 day CCTA is graft assessment and topographical adequacy of the revascularisation procedure. Automatic non-invasive assessment of functional coronary anatomy complexity is also evaluated with FFRCT for functional Synergy Between percutaneous coronary intervention With Taxus and Cardiac Surgery Score assessment on CCTA. CCTA with FFRCT might provide better anatomical and functional analysis of the coronary circulation leading to appropriate anatomical and functional revascularisation, and thereby contributing to a better outcome.Ethics and dissemination Each patient has to provide written informed consent as approved by the ethical committee of the respective clinical site. Results will be submitted for publication in peer-reviewed journals and will be disseminated at scientific conferences.Trial registration number NCT04142021. |
| format | Article |
| id | doaj-art-6bf0a2d4720f498a8d5d90467d7db314 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-6bf0a2d4720f498a8d5d90467d7db3142025-08-20T02:50:25ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-038152Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG studyDaniele Andreini0Kaoru Tanaka1Hideyuki Kawashima2Ronny R Buechel3William Wijns4Torsten Doenst5Jonathon Leipsic6Gregg W Stone7Giulio Pompilio8Antonio L Bartorelli9Saima Mushtaq10Enrico Ferrari11Francesco Maisano12Mark La Meir13Johan De Mey14Ulrich Schneider15Ulf Teichgräber16Faisal Sharif17Robbert de Winter18Brian Thomsen19Charles Taylor20Campbell Rogers21Yoshinobu Onuma22Patrick W Serruys23Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico, Milano, Lombardia, ItalyCentrum voor Hart- en Vaatziekten, UZ Brussel, Brussels, BelgiumDivision of Cardiology, Department of Internal Medicine, Teikyo University, Tokyo, JapanUniversity Hospital and University of Zurich, Zurich, Switzerland²National University of Ireland, Galway, IrelandDepartment of Cardiothoracic Surgery, Jena University Hospital – Friedrich Schiller University of Jena, Jena, Thuringia, GermanyRadiology, St Pauls Hospital, Vancouver, British Columbia, Canada11 The Zena & Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USADepartment of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, ItalyCentro Cardiologico Monzino, IRCCS, Milan, Italy6 Department of Emergency Medicine, Jinnah Postgraduate Medical Centre, Karachi, Sindh, PakistanUniversity Hospital and University of Zurich, Zurich, SwitzerlandValve Center, Ospedale San Raffaele, Milan, ItalyUniversitair Ziekenhuis Brussel, VUB, Brussels, BelgiumUniversitair Ziekenhuis Brussel, VUB, Brussels, BelgiumJena University Hospital, Friedrich-Schiller-University of Jena, Jena, GermanyJena University Hospital, Friedrich-Schiller-University of Jena, Jena, Germany1 BioInnovate Ireland, National University of Ireland Galway, Galway, IrelandAmsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsGE Healthcare, Milwaukee, Wisconsin, USAHeartFlow, Inc, Redwood City, California, USAHeartFlow, Redwood City, CA, USACORRIB Research Center for Advanced Imaging and Core Laboratory, Galway, IrelandNHLI, Imperial College London, London, UKIntroduction The previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from invasive coronary angiography (ICA). The study objective of the FASTTRACK CABG is to assess the feasibility of CCTA and fractional flow reserve derived from CTA (FFRCT) to replace ICA as a surgical guidance method for planning and execution of CABG in patients with three-vessel disease with or without left main disease.Methods and analysis The FASTTRACK CABG is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept and first-in-man study with feasibility and safety analysis. Surgical revascularisation strategy and treatment planning will be solely based on CCTA and FFRCT without knowledge of the anatomy defined by ICA. Clinical follow-up visit including CCTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularisation with respect to the surgical planning based on non-invasive imaging (CCTA) with functional assessment (FFRCT) and compared with ICA. Primary feasibility endpoint is CABG planning and execution solely based on CCTA and FFRCT in 114 patients. Primary safety endpoint based on 30 day CCTA is graft assessment and topographical adequacy of the revascularisation procedure. Automatic non-invasive assessment of functional coronary anatomy complexity is also evaluated with FFRCT for functional Synergy Between percutaneous coronary intervention With Taxus and Cardiac Surgery Score assessment on CCTA. CCTA with FFRCT might provide better anatomical and functional analysis of the coronary circulation leading to appropriate anatomical and functional revascularisation, and thereby contributing to a better outcome.Ethics and dissemination Each patient has to provide written informed consent as approved by the ethical committee of the respective clinical site. Results will be submitted for publication in peer-reviewed journals and will be disseminated at scientific conferences.Trial registration number NCT04142021.https://bmjopen.bmj.com/content/10/12/e038152.full |
| spellingShingle | Daniele Andreini Kaoru Tanaka Hideyuki Kawashima Ronny R Buechel William Wijns Torsten Doenst Jonathon Leipsic Gregg W Stone Giulio Pompilio Antonio L Bartorelli Saima Mushtaq Enrico Ferrari Francesco Maisano Mark La Meir Johan De Mey Ulrich Schneider Ulf Teichgräber Faisal Sharif Robbert de Winter Brian Thomsen Charles Taylor Campbell Rogers Yoshinobu Onuma Patrick W Serruys Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study BMJ Open |
| title | Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study |
| title_full | Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study |
| title_fullStr | Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study |
| title_full_unstemmed | Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study |
| title_short | Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study |
| title_sort | safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary cta and ffrct in patients with complex coronary artery disease study protocol of the fasttrack cabg study |
| url | https://bmjopen.bmj.com/content/10/12/e038152.full |
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