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

Tracking Information
First Submitted Date ICMJE	March 9, 2013
First Posted Date ICMJE	March 13, 2013
Last Update Posted Date	March 13, 2013
Study Start Date ICMJE	March 2013
Estimated Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 11, 2013)	Rate of occluded bypass grafts [ Time Frame: 1 year ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: March 11, 2013)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial
Official Title ICMJE	Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Coronary Artery Disease
Intervention ICMJE	Procedure: Surgical revascularization; The final intervention (surgical revascularization) will be the same for both arms.
Study 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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: March 11, 2013)	206
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 90 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Czech Republic, Hungary
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01810224
Other Study ID Numbers ICMJE	GRAFFITI
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Emanuele Barbato, Onze Lieve Vrouw Hospital
Study Sponsor ICMJE	Onze Lieve Vrouw Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Emanuele Barbato, MD, PhD Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
PRS Account	Onze Lieve Vrouw Hospital
Verification Date	March 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP