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
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: Surgical revascularization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouw Hospital:

Primary Outcome Measures:
  • Rate of occluded bypass grafts [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 206
Study Start Date: March 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Emanuele Barbato, Doctor, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT01810224     History of Changes
Other Study ID Numbers: GRAFFITI
Study First Received: March 9, 2013
Last Updated: March 11, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014