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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Surgical revascularization
Sponsored by
Onze Lieve Vrouw Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Center Aalst OLV HospitalRecruiting
  • Department of Internal Medicine and Cardiology, University Hospital Brno
  • Hungarian Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Angio-guided arm

FFR-guided arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of occluded bypass grafts

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.

Full Information

First Posted
March 9, 2013
Last Updated
March 11, 2013
Sponsor
Onze Lieve Vrouw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01810224
Brief Title
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial
Acronym
GRAFFITI
Official Title
Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onze Lieve Vrouw Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angio-guided arm
Arm Type
Active Comparator
Arm Description
In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.
Arm Title
FFR-guided arm
Arm Type
Experimental
Arm Description
In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.
Intervention Type
Procedure
Intervention Name(s)
Surgical revascularization
Intervention Description
The final intervention (surgical revascularization) will be the same for both arms.
Primary Outcome Measure Information:
Title
Rate of occluded bypass grafts
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuele Barbato, MD, PhD
Email
emanuele.barbato@olvz-aalst.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuele Barbato, MD, PhD
Organizational Affiliation
Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center Aalst OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuele Barbato, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bernard De Bruyne, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gabor Toth, MD
Facility Name
Department of Internal Medicine and Cardiology, University Hospital Brno
City
Brno
Country
Czech Republic
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Kala, MD
Email
kalapetr7@gmail.com
First Name & Middle Initial & Last Name & Degree
Petr Kala, MD
Facility Name
Hungarian Institute of Cardiology
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zsolt Piroth
Email
piroth@freemail.hu
First Name & Middle Initial & Last Name & Degree
Zsolt Piroth, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31270037
Citation
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.
Results Reference
derived
PubMed Identifier
30027499
Citation
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.
Results Reference
derived

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

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