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NCT04142021

Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)

Status unknown Last updated 26 April 2022
What this trial tests

trial testing Coronary computed tomography angiography in Coronary Artery Disease in 114 participants. Status unknown.

Timeline
1 September 2020
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorNational University of Ireland, Galway, Ireland
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment114
Start date1 September 2020
Primary completion31 December 2022
Estimated completion31 December 2022
Sites3 locations across Belgium, Italy, Germany

Drugs / interventions tested

Conditions studied

Sponsor

National University of Ireland, Galway, Ireland

Who can join

18 and older, any sex, with Coronary Artery Disease or Myocardial Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Computed tomographic angiography in coronary artery disease.
    Serruys PW, Kotoku N, Nørgaard BL, Garg S, et al · · 2023 · cited 56× · PMID 37025086 · DOI 10.4244/eij-d-22-00776
  2. Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFR<sub>CT</sub> in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study.
    Kawashima H, Pompilio G, Andreini D, Bartorelli AL, et al · · 2020 · cited 37× · PMID 33303435 · DOI 10.1136/bmjopen-2020-038152
  3. Coronary bypass surgery guided by computed tomography in a low-risk population.
    Serruys PW, Kageyama S, Pompilio G, Andreini D, et al · · 2024 · cited 25× · PMID 38583086 · DOI 10.1093/eurheartj/ehae199
  4. Pre-procedural planning of coronary revascularization by cardiac computed tomography: An expert consensus document of the Society of Cardiovascular Computed Tomography.
    Andreini D, Collet C, Leipsic J, Nieman K, et al · · 2022 · cited 24× · PMID 35994043 · DOI 10.4244/eij-e-22-00036
  5. CCTA-based CABG SYNTAX Score: a tool to evaluate completeness of coronary segment revascularization after bypass surgery.
    Kotoku N, Serruys PW, Kageyama S, Garg S, et al · · 2023 · cited 4× · PMID 37921898 · DOI 10.1007/s10554-023-02978-9
  6. Treatment recommendation based on SYNTAX score 2020 derived from coronary computed tomography angiography and invasive coronary angiography.
    Masuda S, Serruys PW, Kageyama S, Kotoku N, et al · · 2023 · cited 4× · PMID 37368152 · DOI 10.1007/s10554-023-02884-0
  7. Quantitative coronary computed tomography assessment for differentiating between total occlusions and severe stenoses.
    Masuda S, Revaiah PC, Kageyama S, Tsai TY, et al · · 2024 · cited 3× · PMID 38714459 · DOI 10.1016/j.jcct.2024.04.013
  8. Cardiac computed tomography: Current practice, guidelines, applications, and prospects.
    Shih YT, Zhou JH, Hsiao JK. · · 2025 · cited 2× · PMID 40321959 · DOI 10.4103/tcmj.tcmj_125_24

Verify or expand the search:

Other trials of Coronary computed tomography angiography

Trials testing the same drug.

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other National University of Ireland, Galway, Ireland trials

Trials by the same sponsor.

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