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

Primary Purpose

Coronary Artery Disease, Coronary Disease, Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fractional flow reserve-guided CABG
Angiography-guided CABG
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus
  • Anne Langhoff Thuesen
  • Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fractional flow reserve-guided CABG

Angiography-guided CABG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage open grafts of all grafts
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 Outcome Measures

Graft stenosis (shaft and anastomoses)
Change in CCS class from index to follow-up (FU)
CCS class (Canadian Cardiovascular Society grading of angina)
Change in Quality of life (EQ-5D) from index to FU
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)
Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.
Procedure time

Full Information

First Posted
January 19, 2015
Last Updated
October 16, 2018
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02477371
Brief Title
Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
Acronym
FARGO
Official Title
Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arteriosclerosis, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional flow reserve-guided CABG
Arm Type
Experimental
Arm Description
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.
Arm Title
Angiography-guided CABG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fractional flow reserve-guided CABG
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Angiography-guided CABG
Intervention Description
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 Outcome Measure Information:
Title
Percentage open grafts of all grafts
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Graft stenosis (shaft and anastomoses)
Time Frame
6 months
Title
Change in CCS class from index to follow-up (FU)
Description
CCS class (Canadian Cardiovascular Society grading of angina)
Time Frame
6 months
Title
Change in Quality of life (EQ-5D) from index to FU
Time Frame
6 months
Title
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)
Time Frame
6 months
Title
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
Title
Procedure time
Time Frame
During surgery (minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Langhoff Thuesen, MD
Organizational Affiliation
Department of Cardio-thoracic surgery, Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisette Okkels Jensen, MD,PhD,DMSc
Organizational Affiliation
Department of Cardiology, Odense University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Per Thayssen, MD, DMSc
Organizational Affiliation
Department of Cardiology, Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Poul Erik Mortensen, MD
Organizational Affiliation
Department of Cardio-thoracic surgery, Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Anne Langhoff Thuesen
City
Odense
State/Province
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34078097
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.
Results Reference
derived
PubMed Identifier
30497559
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.
Results Reference
derived

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Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

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