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

NCT ID: NCT01810224

Last Updated: 2013-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Angio-guided arm

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

Group Type ACTIVE_COMPARATOR

Surgical revascularization

Intervention Type PROCEDURE

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

FFR-guided arm

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

Group Type EXPERIMENTAL

Surgical revascularization

Intervention Type PROCEDURE

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

Interventions

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Surgical revascularization

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Barbato

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emanuele Barbato, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)

Locations

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Cardiovascular Center Aalst OLV Hospital

Aalst, , Belgium

Site Status RECRUITING

Department of Internal Medicine and Cardiology, University Hospital Brno

Brno, , Czechia

Site Status NOT_YET_RECRUITING

Hungarian Institute of Cardiology

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Countries

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Belgium Czechia Hungary

Central Contacts

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Emanuele Barbato, MD, PhD

Role: CONTACT

Facility Contacts

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Petr Kala, MD

Role: primary

Zsolt Piroth

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31270037 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30027499 (View on PubMed)

Other Identifiers

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GRAFFITI

Identifier Type: -

Identifier Source: org_study_id

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