Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial (FARGO)

October 16, 2018 updated by: Anne Langhoff Thuesen, Odense University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus
    • Odense C
      • Odense, Odense C, Denmark, 5000
        • Anne Langhoff Thuesen

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional flow reserve-guided CABG
Patients are randomized to an FFR-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan form the heart team meeting are changed by the study investigator according to the FFR-measurements and randomization, so that coronary arteries with FFR ≤ 0,8 receive grafting and coronary arteries with FFR > 0,8 are deferred.
Procedure: Fractional flow reserve-guided CABG
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.
Active Comparator: Angiography-guided CABG
Patients are randomized to an angiography-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan are based on the coronary angiography.
Procedure: Angiography-guided CABG
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft stenosis (shaft and anastomoses)
Time Frame: 6 months
6 months
Change in CCS class from index to follow-up (FU)
Time Frame: 6 months
CCS class (Canadian Cardiovascular Society grading of angina)
6 months
Change in Quality of life (EQ-5D) from index to FU
Time Frame: 6 months
6 months
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)
Time Frame: 6 months
6 months
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
The first 24 hours after the operation
Procedure time
Time Frame: During surgery (minutes)
During surgery (minutes)

Collaborators and Investigators

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

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Anne Langhoff Thuesen, MD, Department of Cardio-thoracic surgery, Odense University Hospital
  • Study Director: Lisette Okkels Jensen, MD,PhD,DMSc, Department of Cardiology, Odense University Hospital
  • Study Chair: Per Thayssen, MD, DMSc, Department of Cardiology, Odense University Hospital
  • Study Chair: Poul Erik Mortensen, MD, Department of Cardio-thoracic surgery, Odense University Hospital

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

June 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 22, 2015

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20130050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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