FARGO: Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02477371

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Disease Myocardial Ischemia Arteriosclerosis Cardiovascular Diseases	Procedure: Fractional flow reserve-guided CABG Procedure: Angiography-guided CABG	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage open grafts of all grafts [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 Outcome Measures

Graft stenosis (shaft and anastomoses) [6 months]
Change in CCS class from index to follow-up (FU) [6 months]
CCS class (Canadian Cardiovascular Society grading of angina)
Change in Quality of life (EQ-5D) from index to FU [6 months]
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention) [6 months]
Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions. [The first 24 hours after the operation]
Procedure time [During surgery (minutes)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus	Aarhus	Aarhus N	Denmark	8200
2	Anne Langhoff Thuesen	Odense	Odense C	Denmark	5000
3	Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital	Aalborg		Denmark	9100

Sponsors and Collaborators

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