Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Coronary Artery Disease Clinical Trial

— FARGO  

Official title:

Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477371
• Other study ID #: S-20130050
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital	Aalborg
Denmark	Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus	Aarhus	Aarhus N
Denmark	Anne Langhoff Thuesen	Odense	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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