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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Onze Lieve Vrouw Hospital
Sponsor:
Information provided by (Responsible Party):
Emanuele Barbato, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier:
NCT01810224
First received: March 9, 2013
Last updated: March 11, 2013
Last verified: March 2013

March 9, 2013
March 11, 2013
March 2013
December 2015   (final data collection date for primary outcome measure)
Rate of occluded bypass grafts [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01810224 on ClinicalTrials.gov Archive Site
a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial
Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
  • Active Comparator: Angio-guided arm
    In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.
    Intervention: Procedure: Surgical revascularization
  • Experimental: FFR-guided arm
    In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.
    Intervention: Procedure: Surgical revascularization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
206
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Emanuele Barbato, MD, PhD emanuele.barbato@olvz-aalst.be
Belgium,   Czech Republic,   Hungary
 
NCT01810224
GRAFFITI
No
Emanuele Barbato, Onze Lieve Vrouw Hospital
Onze Lieve Vrouw Hospital
Not Provided
Principal Investigator: Emanuele Barbato, MD, PhD Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
Onze Lieve Vrouw Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP