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)

April 25, 2022 updated by: Patrick Serruys, National University of Ireland, Galway, Ireland

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium
        • Recruiting
        • University Hospital of Brussels
        • Contact:
          • Mark La Meir, MD, PhD
        • Contact:
          • Johan de Mey, MD, PhD
  • Germany
      • Jena, Germany
        • Recruiting
        • University Hospital of Jena
        • Contact:
          • Torsten Doenst, MD, PhD
        • Contact:
          • Ulf Teichgräber, MD
  • Italy
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino
        • Contact:
          • Giulio Pompilio, MD, PhD
        • Contact:
          • Daniele Andreini, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with 3-vessel disease with or without left main involvement referred to CABG treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 weeks after enrollment
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
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Ireland, Galway, Ireland

Collaborators

GE Healthcare
HeartFlow, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASTTRACK CABG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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