Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial (GRAFFITI)
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ClinicalTrials.gov Identifier: NCT01810224 |
Recruitment Status
: Unknown
Verified March 2013 by Emanuele Barbato, Onze Lieve Vrouw Hospital.
Recruitment status was: Recruiting
First Posted
: March 13, 2013
Last Update Posted
: March 13, 2013
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Procedure: Surgical revascularization | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 206 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Angio-guided arm
In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.
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Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
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Experimental: FFR-guided arm
In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.
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Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
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- Rate of occluded bypass grafts [ Time Frame: 1 year ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810224
Contact: Emanuele Barbato, MD, PhD | emanuele.barbato@olvz-aalst.be |
Belgium | |
Cardiovascular Center Aalst OLV Hospital | Recruiting |
Aalst, Belgium, 9300 | |
Principal Investigator: Emanuele Barbato, MD, PhD | |
Principal Investigator: Bernard De Bruyne, MD, PhD | |
Principal Investigator: Gabor Toth, MD | |
Czech Republic | |
Department of Internal Medicine and Cardiology, University Hospital Brno | Not yet recruiting |
Brno, Czech Republic | |
Contact: Petr Kala, MD kalapetr7@gmail.com | |
Principal Investigator: Petr Kala, MD | |
Hungary | |
Hungarian Institute of Cardiology | Not yet recruiting |
Budapest, Hungary | |
Contact: Zsolt Piroth piroth@freemail.hu | |
Principal Investigator: Zsolt Piroth, MD, PhD |
Principal Investigator: | Emanuele Barbato, MD, PhD | Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium) |
Responsible Party: | Emanuele Barbato, Doctor, Onze Lieve Vrouw Hospital |
ClinicalTrials.gov Identifier: | NCT01810224 History of Changes |
Other Study ID Numbers: |
GRAFFITI |
First Posted: | March 13, 2013 Key Record Dates |
Last Update Posted: | March 13, 2013 |
Last Verified: | March 2013 |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |