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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
Sponsor:
Information provided by (Responsible Party):
Emanuele Barbato, Onze Lieve Vrouw Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Surgical revascularization Phase 4

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Angio-guided arm
In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.
 Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
Experimental: FFR-guided arm
In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.
 Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of occluded bypass grafts [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Emanuele Barbato, MD, PhD emanuele.barbato@olvz-aalst.be

Locations
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         
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
Principal Investigator: Emanuele Barbato, MD, PhD Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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