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NCT01810224 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— GRAFFITI  

Official title:
Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01810224
Other study ID # GRAFFITI
Secondary ID
Status Recruiting
Phase Phase 4
First received March 9, 2013
Last updated March 11, 2013
Start date March 2013

Study information
Verified date March 2013
Source Onze Lieve Vrouw Hospital
Contact Emanuele Barbato, MD, PhD
Email emanuele.barbato@olvz-aalst.be
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 206
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.

Locations
Country Name City State
Belgium Cardiovascular Center Aalst OLV Hospital Aalst
Czech Republic Department of Internal Medicine and Cardiology, University Hospital Brno Brno
Hungary Hungarian Institute of Cardiology Budapest

Sponsors (1)
Lead Sponsor Collaborator
Onze Lieve Vrouw Hospital

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of occluded bypass grafts 1 year Yes
Secondary 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 Yes
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