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Completed

NCT Number: NCT02477371

Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus, Aarhus, Aarhus N, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fractional flow reserve-guided CABG

Procedure

Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting and where FFR-measurements are made, only receive grafting if FFR-value is ≤ 0,8. Arteries with FFR-values > 0,8 are deferred.

Angiography-guided CABG

Procedure

Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting all receive grafting. FFR-measurements are still made, but not used for guidance of grafting.

Primary outcomes

  1. Percentage open grafts of all grafts

    Time frame: 6 months

    Open graft definition: graft with TIMI III flow with no anastomosis stenosis (TIMI flow grades based on results of the Thrombolysis In Myocardial Infarction trial)

Secondary outcomes

  1. Graft stenosis (shaft and anastomoses)

    Time frame: 6 months

  2. Change in CCS class from index to follow-up (FU)

    Time frame: 6 months

    CCS class (Canadian Cardiovascular Society grading of angina)

  3. Change in Quality of life (EQ-5D) from index to FU

    Time frame: 6 months

  4. MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)

    Time frame: 6 months

  5. Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.

    Time frame: The first 24 hours after the operation

  6. Procedure time

    Time frame: During surgery (minutes)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Acronym: FARGO

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2015
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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