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)

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04142021
• Other study ID #: FASTTRACK CABG
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: National University of Ireland, Galway, Ireland
• Contact: Hideyuki Kawashima, MD
• Phone: +353870696945
• Email: h.kawashima429[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Vascular Diseases

Intervention

Diagnostic Test:
• Coronary computed tomography angiography
Surgery planning done based solely on coronary computed tomography angiography.

Locations

Country	Name	City	State
Belgium	University Hospital of Brussels	Brussels
Germany	University Hospital of Jena	Jena
Italy	Centro Cardiologico Monzino	Milan

Sponsors (3)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	GE Healthcare, HeartFlow, Inc.

Countries where clinical trial is conducted

Belgium,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].		2 weeks after enrollment
Primary	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		1 month after surgery