Coronary Artery Disease
Conditions
Brief summary
This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting.
Interventions
PROCEDURESurgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
Sponsors
Onze Lieve Vrouw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with stable angina, unstable angina or NSTEMI candidate to CABG * Significant LAD and/or LM lesion - proved by FFR or Angiography AND * At least one more, angiographycally intermediate lesion
Exclusion criteria
* Significant valvular disease with indication to surgical replacement * Severe left ventricular dysfunction (EF\<35%) * Acute STEMI * Atrial fibrillation, if Maze procedure is planned
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of occluded bypass grafts | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches. | participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks |
Countries
Belgium, Czechia, Hungary
Contacts
Primary ContactEmanuele Barbato, MD, PhD
Outcome results
None listed