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

March 11, 2013 updated by: Emanuele Barbato, Onze Lieve Vrouw Hospital

Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • Cardiovascular Center Aalst OLV Hospital
        • Principal Investigator:
          • Gabor Toth, MD
        • Principal Investigator:
          • Emanuele Barbato, MD, PhD
        • Principal Investigator:
          • Bernard De Bruyne, MD, PhD
  • Czech Republic
      • Brno, Czech Republic
        • Not yet recruiting
        • Department of Internal Medicine and Cardiology, University Hospital Brno
        • Contact:
        • Principal Investigator:
          • Petr Kala, MD
  • Hungary
      • Budapest, Hungary
        • Not yet recruiting
        • Hungarian Institute of Cardiology
        • Contact:
        • Principal Investigator:
          • Zsolt Piroth, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of occluded bypass grafts
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouw Hospital

Investigators

  • Principal Investigator: Emanuele Barbato, MD, PhD, Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 9, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 11, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAFFITI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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