Coronary Artery DiseasePhase 4GRAFFITINCT01810224
Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial
A Phase 4 study testing Surgical revascularization in people with Coronary Artery Disease, run by Onze Lieve Vrouw Hospital at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Surgical revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant valvular disease with indication to surgical replacement
- Severe left ventricular dysfunction (EF<35%)
- Acute STEMI
- Atrial fibrillation, if Maze procedure is planned
Trial locations and contacts
3 sites in 3 countries.
Emanuele Barbato, MD, PhD contact
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
Cardiovascular Center Aalst OLV Hospital
Aalst, 9300
Emanuele Barbato, MD, PhD
Bernard De Bruyne, MD, PhD
Czechia1 site, 1 recruiting
- Not yet recruiting
Department of Internal Medicine and Cardiology, University Hospital Brno
Brno
Petr Kala, MD, kalapetr7@gmail.com
Petr Kala, MD
Hungary1 site, 1 recruiting
- Not yet recruiting
Hungarian Institute of Cardiology
Budapest
Zsolt Piroth, piroth@freemail.hu
Zsolt Piroth, MD, PhD
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Surgical revascularization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical revascularizationProcedure or surgery
The final intervention (surgical revascularization) will be the same for both arms.
| Study group | Role | What they receive |
|---|---|---|
| Angio-guided arm | Active comparator | In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy. Receives: Procedure: Surgical revascularization |
| FFR-guided arm | Experimental | In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy. Receives: Procedure: Surgical revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occluded bypass grafts
Measured: 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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Barbato, Onze Lieve Vrouw Hospital
- Investigators
- Emanuele Barbato, MD, PhD, Principal investigator, Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810224
- Sponsor's protocol ID
- GRAFFITI
- Acronym
- GRAFFITI
- Status last verified
- Mar 2013
- First submitted
- 9 Mar 2013
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31270037Toth 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.
PubMed 30027499
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial
- ClinicalTrials.gov ID
- NCT01810224
- Acronym / sponsor ID
- GRAFFITI / GRAFFITI
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angio-guided arm | Active comparator | Procedure: Surgical revascularizationIn this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy. |
| FFR-guided arm | Experimental | Procedure: Surgical revascularizationIn this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Significant valvular disease with indication to surgical replacement
- Severe left ventricular dysfunction (EF<35%)
- Acute STEMI
- Atrial fibrillation, if Maze procedure is planned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical revascularizationThe final intervention (surgical revascularization) will be the same for both arms. | Procedure or surgery | Angio-guided arm, FFR-guided arm |
Primary outcome
Rate of occluded bypass grafts
Time frame: 1 year
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 31270037Toth 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.
- Derived from this study: PubMed 30027499Toth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Barbato, MD, PhD contact
Emanuele Barbato, MD, PhD principal investigator
Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Surgical revascularization in people with Coronary Artery Disease, run by Onze Lieve Vrouw Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Czechia, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Barbato, MD, PhD (emanuele.barbato@olvz-aalst.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occluded bypass grafts (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.