NCT02477371

Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-06-22
• Last updated: 2018-10-18

Locations

3 sites across 1 country: Denmark