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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142021
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Collaborators:
GE Healthcare
HeartFlow, Inc.
Information provided by (Responsible Party):
Patrick W. Serruys, Imperial College London

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Diagnostic Test: Coronary computed tomography angiography

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Study Type : Observational
Estimated Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Pilot Study to Evaluate 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)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with 3-vessel disease with or without left main
Patients with 3-vessel disease with or without left main involvement referred to CABG treatment based on coronary angiography.
Diagnostic Test: Coronary computed tomography angiography
Surgery planning done based solely on coronary computed tomography angiography.




Primary Outcome Measures :
  1. Feasibility expressed in percentage of CABG planning and execution solely based on coronary CTA in 114 candidates for CABG (i.e. the 'CTA heart team' and the operator being blind for the ICA). [percentage/rate]. [ Time Frame: 2 weeks after enrollment ]
  2. Safety: The rate of graft stenosis [≥ 50% diameter stenosis (DS) - 99% DS] or occlusion (100% DS) either at the ostium, in the shaft or at the level of the sequential anastomosis or at the distal anastomosis of each individual graft based on coronary CTA [ Time Frame: 1 month after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with 3-vessel disease with or without left main involvement referred to CABG treatment.
Criteria

Inclusion Criteria:

  • Patients referred to CABG treatment (as assessed by 'conventional heart team') having at the time of the conventional heart team evaluation at least 1 de novo stenotic lesion (with a visually assessed DS with ≥ 50%) in all 3 major epicardial territories [left anterior descending (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, right coronary artery (RCA) and/or side branch] supplying viable myocardium with or without left main involvement
  • Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and LCX territories may be included in the trial as a 3VD equivalent. Ostial LAD plus ostial LCX may be included in the trial as a left main equivalent
  • Distal vessel size should be at least 1.5 mm in diameter as visually assessed in the diagnostic angiogram (as requested by the surgeons)
  • Patients with silent ischemia, chronic coronary syndrome or stabilized acute coronary syndrome with normalized (stable or decreasing) cardiac biomarker values. For patients showing elevated troponin (cTn) (e.g. non-ST elevation myocardial infarction [NSTEMI] patients) at baseline (within 24h pre-CABG) an additional blood sample must be collected prior to CABG to confirm that: a) hs-cTn or troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped 25; b) creatine kinase-muscle/brain (CK-MB) and creatine kinase (CK) levels are within normal range. If hs-cTn or troponin I or T levels are stable or have dropped, or the CK-MB and CK levels are within normal ranges and the ECG is normal, patients may be included in the study
  • All anatomical SYNTAX Scores are eligible
  • Patients are amenable to coronary CTA (e.g. no claustrophobia, high heart rate not amenable to beta-blockers, poor renal function, etc., up to the discretion of the investigator)
  • Patients have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the Ethical Committee of the respective clinical site
  • Patients agree to 1-month follow-up visit including coronary CTA

Exclusion Criteria:

  • Under the age of 18 years
  • Unable to give informed consent
  • Known pregnancy at the time of enrollment; female of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause); female who is breastfeeding at time of enrollment
  • Prior PCI or CABG; history of coronary stent implantation
  • Evidence of evolving or ongoing ST-elevation MI (STEMI) on ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of enrollment (non-STEMI)
  • Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or need for dialysis, or acute kidney failure (as per physician judgment)
  • Concomitant cardiac valve disease requiring surgical therapy (repair or replacement) and/or aneurysmectomy
  • Single or two-vessel disease (at time of the conventional heart team consensus)
  • Non-graftable distal bed in >1 vessel as assessed by the surgeon based on ICA
  • Persistent atrial fibrillation or significant arrhythmias
  • Known allergy to iodinated contrast
  • A body mass index (BMI) of 35 or greater
  • Currently participating in another clinical trial not yet at its primary endpoint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142021


Contacts
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Contact: Hideyuki Kawashima, MD +3117287082 h.kawashima429@icloud.com

Locations
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Belgium
University Hospital of Brussels
Brussels, Belgium
Contact: Mark La Meir, MD, PhD         
Contact: Johan de Mey, MD, PhD         
Germany
University Hospital of Jena
Jena, Germany
Contact: Torsten Doenst, MD, PhD         
Contact: Ulf Teichgräber, MD         
Italy
Centro Cardiologico Monzino
Milan, Italy
Contact: Giulio Pompilio, MD, PhD         
Contact: Daniele Andreini, MD, PhD         
Switzerland
University Hospital of Zurich
Zürich, Switzerland
Contact: Andre Plass, MD         
Sponsors and Collaborators
Imperial College London
GE Healthcare
HeartFlow, Inc.

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Responsible Party: Patrick W. Serruys, Professor / Chairman of the study, Imperial College London
ClinicalTrials.gov Identifier: NCT04142021    
Other Study ID Numbers: FASTTRACK CABG
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy.

Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick W. Serruys, Imperial College London:
coronary artery bypass graft
coronary computed tomography angiography
fractional flow reserve derived from computed tomography angiography
invasive coronary angiography, revascularization
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Cardiovascular Diseases
Pathologic Processes