Clinical trial NCT02477371: Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
Official title: Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Cardiovascular Diseases
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.

Detailed description: FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.

Eligibility criteria: Inclusion Criteria:

* Stable angina or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG
* At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter\> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.)
* Signed informed consent form

Exclusion Criteria:

* Significant valvular disease with indication to surgical treatment
* Previous open-heart-surgery
* Left main lesion without other intermediate lesions
* Treatment with Persantin Retard
* One vessel disease
* Renal impairment (creatinine ≥ 150 umol / l)

Primary outcomes:
measure: Percentage open grafts of all grafts
timeFrame: 6 months
Secondary outcomes:
measure: Graft stenosis (shaft and anastomoses)
timeFrame: 6 months
measure: Change in CCS class from index to follow-up (FU)
timeFrame: 6 months
measure: Change in Quality of life (EQ-5D) from index to FU
timeFrame: 6 months
measure: MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)
timeFrame: 6 months
measure: Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.
timeFrame: The first 24 hours after the operation
measure: Procedure time
timeFrame: During surgery (minutes)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus
state: Aarhus N
city: Odense
country: Denmark
facility: Anne Langhoff Thuesen
state: Odense C
city: Aalborg
country: Denmark
facility: Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital
Study officials:
affiliation: Department of Cardio-thoracic surgery, Odense University Hospital
name: Anne Langhoff Thuesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Odense University Hospital
name: Lisette Okkels Jensen, MD,PhD,DMSc
role: STUDY_DIRECTOR
affiliation: Department of Cardiology, Odense University Hospital
name: Per Thayssen, MD, DMSc
role: STUDY_CHAIR
affiliation: Department of Cardio-thoracic surgery, Odense University Hospital
name: Poul Erik Mortensen, MD
role: STUDY_CHAIR
References:
citation: Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Borregaard B, Junker A, Mortensen PE, Jensen LO. Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization). Circ Cardiovasc Qual Outcomes. 2021 Jun;14(6):e007302. doi: 10.1161/CIRCOUTCOMES.120.007302. Epub 2021 Jun 3.
citation: Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.