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

This study is currently recruiting participants.
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
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 April 15, 2014