Multivessel Coronary Artery DiseaseMERGINGNCT02226900
Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
A study testing Hybrid Revascularization and Conventional Coronary Artery Bypass Surgery in people with Multivessel Coronary Artery Disease, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- Hybrid Revascularization and Conventional Coronary Artery Bypass Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Dec 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
- Total SYNTAX score > 22
- LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated
- Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus
- Interventionalist determines PCI appropriateness and eligibility
- Surgeon determines surgical appropriateness and eligibility
Show all 9Show fewer
- Silent ischemia, stable angina, unstable angina or recent MI
- If recent MI, cardiac biomarkers must have returned to normal prior to randomization
- Ability to sign informed consent and comply with all study procedures
Who cannot join
- Prior PCI or CABG at any time prior to randomization
- Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
- Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
- Patients requiring additional surgery (cardiac or non cardiac) within one year
- The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented)
- The presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by CABG, but rather should be managed with PCI. or medical therapy - reasons will be documented)
- Non cardiac co-morbidities with life expectancy less than 1 year
- Other investigational drug or device studies that have not reached their primary endpoint.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
InCor -Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000
About this study
This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.
- Conditions
- Multivessel Coronary Artery Disease
- Being tested
- Hybrid Revascularization, Conventional Coronary Artery Bypass Surgery
- Keywords
- Multivessel Coronary Artery Disease, Hybrid Revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid RevascularizationProcedure or surgery
Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.
Conventional Coronary Artery Bypass SurgeryProcedure or surgery
Also called Surgery
On pump coronary artery by-pass surgery
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Revascularization | Experimental | The hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions. Receives: Procedure: Hybrid Revascularization |
| Conventional Surgical Coronary Bypass Grafting | Other | Conventional Coronary Artery Bypass Grafts with in pump technique. Receives: Procedure: Conventional Coronary Artery Bypass Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Revascularization Procedure Proposed by the Heart Team
The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.
Measured: 30 days
Secondary outcomes (16)
Major Adverse Cardiovascular Events
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
Measured: 1 year
Major Adverse Cardiovascular Events
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
Measured: 2 years
Major Adverse Cardiovascular Events
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
Measured: 3 years
Major Adverse Cardiovascular Events
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
Measured: 4 years
Major Adverse Cardiovascular Events
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
Measured: 5 years
Major Adverse Cardiovascular Events
Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.
Measured: 180 days
Safety
Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.
Measured: 1 year
Recurrence of Angina
Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
Measured: 1 year
Medication Impact
Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.
Measured: 1 year
Stent Thrombosis
Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria
Measured: 1 year
Bleeding
Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria
Measured: 1 year
Neurological Events
Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.
Measured: 1 year
Graft Patency
Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography
Measured: 1 year
Clinical and Angiographic Scores Correlation with Prognostic
Evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNTAX score, ACEF score, clinical SYNTAX score, logistic EuroSCORE, STS score and InsCor for prognostic evaluation
Measured: 1 year
Efficacy of the Strategy
Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.
Measured: 1 year
Symptomatic Graft Occlusion
Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.
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 posted27 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Pedro A. Lemos, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226900
- Sponsor's protocol ID
- MERGING
- Acronym
- MERGING
- Status last verified
- Nov 2018
- First submitted
- 21 Aug 2014
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
- ClinicalTrials.gov ID
- NCT02226900
- Acronym / sponsor ID
- MERGING / MERGING
- Conditions
- Multivessel Coronary Artery Disease
- Keywords
- Multivessel Coronary Artery Disease, Hybrid Revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (estimated)
- First posted
- 27 Aug 2014 (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 a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Revascularization | Experimental | Procedure: Hybrid RevascularizationThe hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions. |
| Conventional Surgical Coronary Bypass Grafting | Other | Procedure: Conventional Coronary Artery Bypass SurgeryConventional Coronary Artery Bypass Grafts with in pump technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
- Total SYNTAX score > 22
- LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated
- Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus
- Silent ischemia, stable angina, unstable angina or recent MI
Key exclusion criteria (8 listed)
- Prior PCI or CABG at any time prior to randomization
- Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
- Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
- Patients requiring additional surgery (cardiac or non cardiac) within one year
- The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented)
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 |
|---|---|---|
| Hybrid RevascularizationOff-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories. | Procedure or surgery | Hybrid Revascularization |
| Conventional Coronary Artery Bypass SurgeryAlso: SurgeryOn pump coronary artery by-pass surgery | Procedure or surgery | Conventional Surgical Coronary Bypass Grafting |
Primary outcome
Feasibility of Revascularization Procedure Proposed by the Heart Team
Time frame: 30 days
The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.
16 secondary outcomes
Major Adverse Cardiovascular Events
Time frame: 1 year
Major Adverse Cardiovascular Events
Time frame: 2 years
Major Adverse Cardiovascular Events
Time frame: 3 years
Major Adverse Cardiovascular Events
Time frame: 4 years
Major Adverse Cardiovascular Events
Time frame: 5 years
Major Adverse Cardiovascular Events
Time frame: 180 days
Safety
Time frame: 1 year
Recurrence of Angina
Time frame: 1 year
Medication Impact
Time frame: 1 year
Stent Thrombosis
Time frame: 1 year
Bleeding
Time frame: 1 year
Neurological Events
Time frame: 1 year
Graft Patency
Time frame: 1 year
Clinical and Angiographic Scores Correlation with Prognostic
Time frame: 1 year
Efficacy of the Strategy
Time frame: 1 year
Symptomatic Graft Occlusion
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 29 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Revascularization and Conventional Coronary Artery Bypass Surgery in people with Multivessel Coronary Artery Disease, run by InCor Heart Institute at 1 site in Brazil.
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 9 inclusion and 8 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Revascularization Procedure Proposed by the Heart Team (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.