NCT01810224

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

March 9, 2013

Last Update Submit

March 11, 2013

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of occluded bypass grafts

    1 year

Secondary Outcomes (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.

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

Study Arms (2)

Angio-guided arm

ACTIVE COMPARATOR

In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.

Procedure: Surgical revascularization

FFR-guided arm

EXPERIMENTAL

In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.

Procedure: Surgical revascularization

Interventions

Surgical revascularizationPROCEDURE

The final intervention (surgical revascularization) will be the same for both arms.

Angio-guided armFFR-guided arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Significant valvular disease with indication to surgical replacement
  • Severe left ventricular dysfunction (EF\<35%)
  • Acute STEMI
  • Atrial fibrillation, if Maze procedure is planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardiovascular Center Aalst OLV Hospital

Aalst, 9300, Belgium

RECRUITING

Department of Internal Medicine and Cardiology, University Hospital Brno

Brno, Czechia

NOT YET RECRUITING

Hungarian Institute of Cardiology

Budapest, Hungary

NOT YET RECRUITING

Related Publications (2)

  • Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Piccoli A, Van Mieghem C, Penicka M, Mates M, Nemec P, Van Praet F, Stockman B, Degriek I, Barbato E. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019 Dec 6;15(11):e999-e1005. doi: 10.4244/EIJ-D-19-00463.

    PMID: 31270037DERIVED

  • Toth GG, De Bruyne B, Kala P, Ribichini FL, Casselman F, Ramos R, Piroth Z, Fournier S, Van Mieghem C, Penicka M, Mates M, Van Praet F, Degriek I, Barbato E. Study Design of the Graft Patency After FFR-Guided Versus Angiography-Guided CABG Trial (GRAFFITI). J Cardiovasc Transl Res. 2018 Aug;11(4):269-273. doi: 10.1007/s12265-018-9818-9. Epub 2018 Jul 19.

    PMID: 30027499DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Emanuele Barbato, MD, PhD

    Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuele Barbato, MD, PhD

CONTACT

emanuele.barbato@olvz-aalst.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 9, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

BE(1)CZ(1)HU(1)