Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial

Onze Lieve Vrouw Hospital

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: Surgical revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT01810224

GRAFFITI

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 2 patient groups

Angio-guided arm

Active Comparator group

Description:

In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.

Treatment:

Procedure: Surgical revascularization

FFR-guided arm

Experimental group

Description:

In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.

Treatment:

Procedure: Surgical revascularization