Multivessel Coronary Artery DiseasePhase 3FAIONCT02637440
The Use Of FFR Guided PCI Versus Complete Revascularization and Treatment Of Infarct Related Artery Only In Patients With STEMI
A Phase 3 study testing FFR guided PCI and Angio guided PCI in people with Multivessel Coronary Artery Disease and STEMI, run by University of Limerick at 2 sites in Ireland.
Trial summary
In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease, STEMI, FFR Guided PCI
- What is being tested?
- FFR guided PCI and Angio guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesIreland
- Study dates
- Dec 2015to Nov 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with STEMI and multi-vessel disease on initial angiogram.
- Above 18 years of age
- Able to give consent
Who cannot join
- Patients with indication for CABG
- Left main stem lesion of >50%
- Cardiogenic shock
- Intractable angina during hospital admission
- Patients with limited life expectancy
- Patients with severe chronic kidney disease
Show all 9Show fewer
- Patients with contraindication to dual antiplatelet therapy
- Patients with very complex lesions that deemed not favourable for PCI
- Pregnancy or childbearing age
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Galway University Hospital
Galway, Galway
Brian Hynes, MRCPI
University Hospital Limerick
Limerick, Limerick, 000
Abdullah S Abdullah, MBBS, MSc
About this study
Official title: Multi Centre Open Label Randomised Controlled Parallel-group Three Arm Trial To Compare The Use Of Fractional Flow Reserve (FFR) Guided and Angiographically Guided Revascularization To The Treatment Of Infarct Related Artery Only In Patients With STEMI And Multivessel Disease
In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.
The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well.
Read more
The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention.
In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization
Read the detailed description
To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization.
Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.
- Conditions
- Multivessel Coronary Artery Disease, STEMI, FFR Guided PCI
- Being tested
- FFR guided PCI, Angio guided PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR guided PCIProcedure or surgery
Patients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8
Angio guided PCIProcedure or surgery
Patients receive PCI without FFR measurement
| Study group | Role | What they receive |
|---|---|---|
| Conservative | No intervention | After the index primary PCI. The control group will receive best medical therapy and regular follow up and only PCI for recurrent angina with evidence of inducible ischaemia. |
| FFR guided | Active comparator | FFR group will undergo FFR at 4 weeks of the index primary PCI as OPD. If FFR is less than 0.8, then PCI will be performed Receives: Procedure: FFR guided PCI |
| angiogram guided | Active comparator | The group will undergo PCI for all significant lesions more than 50 Receives: Procedure: Angio guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of cardiovascular death, myocardial infarction and / or revascularization
Measured: 1 year
Secondary outcomes (6)
Cardiovascular morality
Measured: 1 year
Myocardial infarction
Measured: 1 year
Revascularization
Revascularization procedure because of symptoms and evidence of ischaemia
Measured: 1 year
stroke
Measured: 1 year
Heart failure
documented episode of presentation with symptoms consistent with heart failure and evidence from echocardiogram or laboratory test consistent with the diagnosis of heart failure
Measured: 1 year
Costs
total procedural costs, hospital stay costs, medications costs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multivessel 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Abdullah, University of Limerick
- Investigators
- Thomas J Kiernan, MD, Principal investigator, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637440
- Sponsor's protocol ID
- FA 2015
- Acronym
- FAIO
- Status last verified
- Dec 2015
- First submitted
- 17 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.
PubMed 25766941Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available.
PubMed 26498666Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.
PubMed 26347918
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Centre Open Label Randomised Controlled Parallel-group Three Arm Trial To Compare The Use Of Fractional Flow Reserve (FFR) Guided and Angiographically Guided Revascularization To The Treatment Of Infarct Related Artery Only In Patients With STEMI And Multivessel Disease
- ClinicalTrials.gov ID
- NCT02637440
- Acronym / sponsor ID
- FAIO / FA 2015
- Conditions
- Multivessel Coronary Artery Disease, STEMI, FFR Guided PCI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 Dec 2015 (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.
In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries.
The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well.
The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention.
In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization
Detailed description
To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization.
Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative | No intervention | –After the index primary PCI. The control group will receive best medical therapy and regular follow up and only PCI for recurrent angina with evidence of inducible ischaemia. |
| FFR guided | Active comparator | Procedure: FFR guided PCIFFR group will undergo FFR at 4 weeks of the index primary PCI as OPD. If FFR is less than 0.8, then PCI will be performed |
| angiogram guided | Active comparator | Procedure: Angio guided PCIThe group will undergo PCI for all significant lesions more than 50 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with STEMI and multi-vessel disease on initial angiogram.
- Above 18 years of age
- Able to give consent
Key exclusion criteria (9 listed)
- Patients with indication for CABG
- Left main stem lesion of >50%
- Cardiogenic shock
- Intractable angina during hospital admission
- Patients with limited life expectancy
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 |
|---|---|---|
| FFR guided PCIPatients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8 | Procedure or surgery | FFR guided |
| Angio guided PCIPatients receive PCI without FFR measurement | Procedure or surgery | angiogram guided |
Primary outcome
Composite of cardiovascular death, myocardial infarction and / or revascularization
Time frame: 1 year
6 secondary outcomes
Cardiovascular morality
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Revascularization
Time frame: 1 year
stroke
Time frame: 1 year
Heart failure
Time frame: 1 year
Costs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Background: PubMed 25766941Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.
- Results publication: PubMed 26498666Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available.
- Results publication: PubMed 26347918Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.
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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.
Thomas J Kiernan, MD principal investigator
University Hospital of Limerick
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FFR guided PCI and Angio guided PCI in people with Multivessel Coronary Artery Disease and STEMI, run by University of Limerick at 2 sites in Ireland.
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 9 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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Thomas J Kiernan, MD (+35361482684, tom_kiernan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular death, myocardial infarction and / or revascularization (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 NCT02637440, which also lists 3 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 23 Dec 2015.