Coronary Artery DiseaseNCT02047266
Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting
A study testing MICS CABG, OPCABG and ONCABG in people with Coronary Artery Disease and Myocardial Ischemia, run by Vitebsk Regional Clinical Hospital at 1 site in Belarus.
Trial summary
The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG. The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Heart Diseases
- What is being tested?
- MICS CABG, OPCABG and ONCABG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelarus
- Study dates
- Jan 2014to Jun 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multi-vessel coronary artery disease with ≥ 70% artery stenosis (according to QCA)
- II-IV Canadian Cardiovascular Society functional class of angina
- Patients at 1 month after acute myocardial infarction
- Ability to perform either of revascularization methods (MICS CABG, OPCABG, ONCABG)
- Patients must have signed an informed consent
Who cannot join
- Pregnancy.
- Acute coronary syndrome.
- Previous CABG.
- Severe comorbidity with high procedural risk for either of the studied strategies.
- Mental diseases which block the revascularization procedure.
- Severe peripheral artery disease.
Show all 11Show fewer
- Other serious diseases limiting life expectancy (e.g. oncology)
- Inability for long-term follow-up.
- Participation in other clinical trials.
- Single vessel disease.
- Need for emergency revascularization (Acute MI, Acute coronary syndrome etc.)
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Vitebsk regional clinical hospital
Vitebsk, Vitebsk Oblast, 210037
Aliaksandr A Ziankou, MD, PhD
Mikalai G Laiko, MD, +375333050458, Nikolay99@mail.ru
About this study
Official title: Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting (MICS CABG) Versus Off Pump (OPCABG) and on Pump Coronary Artery Bypass Grafting (ONCABG) in Patients With Multi-vessel Coronary Disease
The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.
The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.
Read the detailed description
Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:
- MICS CABG. Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy). (MICS CABG group, n=50).
- OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
- ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). The endpoints: The primary endpoints will be death, MI, stroke, or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days, 12 months and 3-year follow-up.
The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and number of transfusions, Wound complications, Recovery time, Heart Failure (New York Heart Association (NYHA)), Life quality assessed by one of the life quality questionnaires.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Heart Diseases
- Being tested
- MICS CABG, OPCABG, ONCABG, Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®), Starfish®, Octopus®, Clearview® blower, ClearView® Shunt
- Keywords
- MICS CABG OPCABG ONCABG CAD
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICS CABGProcedure or surgery
Minimally invasive coronary artery bypass grafting - beating heart multi-vessel procedure in which the anastomoses are performed under direct vision through a lateral left mini-thoracotomy. The left internal thoracic artery is used to graft the left anterior descending artery or circumflex artery territories. Radial artery or saphenous vein are used (Y - grafts) to graft another myocardial territories. Right internal thoracic artery can be used as free Y-graft, as in-situ graft with radial artery (extension technique) or as in-situ graft without composite technique. Right gastroepiploic artery can be used to graft right coronary artery territory. Hybrid approach (MICS CABG + PCI), parallel transfemoral extracorporeal circulation without cardioplegia and CABG from the ascending aorta are acceptable for achievement of the complete revascularization.
OPCABGProcedure or surgery
Off-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Mechanical Devices are used for coronary artery stabilization and heart positioning. Pericardial traction sutures are used to position the heart where appropriate. Blowers and Intracoronary shunts are used routinely. Anticoagulation is obtained using sodium heparin at a dose of 2mg/kg with supplemental doses to maintain adequate heparinisation (Activated clotting time>250seconds).
ONCABGProcedure or surgery
On-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Normothermic cardiopulmonary bypass and complex blood ante-retrograde cardioplegia are used. All patients are cannulated with an proximal aortic cannula and two-stage right atrial cannula. Extracorporeal circulation is provided by the Terumo System-1 heart-lung machine using cardiopulmonary bypass systems with physiological surfaces and opened venous reservoirs. The left internal thoracic artery is used to graft the left anterior descending artery, and radial artery or saphenous vein segments are used to graft another myocardial territories. Anticoagulation is obtained using sodium heparin at a dose of 3mg/kg (ACT, activated clotting time>450seconds).
Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®)Device
Octopus® Nuvo - MICS CABG tissue stabilizer available for minimally invasive procedures. It minimizes the motion of a small area of the heart while the rest of the heart continues to beat normally and allows to perform anastomosis through a small incision. Starfish® Non-Sternotomy (NS) - MICS CABG heart positioner available for minimally invasive procedures. It allows for the positioning of the beating heart through a small incision, bringing coronary targets into the operative thoracotomy window. ThoraTrak® - a reusable, stainless steel MICS thoracic retractor system for minimally invasive heart surgery with multiple interchangeable blades, which allows to harvest left internal thoracic artery and to perform anastomosis through a small left thoracotomy(Medtronic, Inc., Minneapolis, MN).
Starfish®, Octopus®, Clearview® blower, ClearView® ShuntDevice
Starfish® - heart positioner is designed to position and to hold the heart to give the surgeon easy access to the vessel requiring the bypass graft. Octopus® - tissue stabilizer minimizes / limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping of the heart and without using the heart-lung machine. ClearView® Blower is designed to improve visualization of the surgical site. An irrigation mist gently clears blood from the site, improving visualization without drying or desiccating delicate tissue. The ClearView® shunt - Intracoronary shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium (Medtronic, Inc., Minneapolis, MN)
| Study group | Role | What they receive |
|---|---|---|
| MICS CABG | Experimental | Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy), which is performed with a help of Octopus® Nuvo, Starfish® Non-Sternotomy, ThoraTrak®, Starfish®, Octopus®, Clearview® blower, ClearView® Shunt.
(MICS CABG group, n=50) Receives: Procedure: MICS CABG; Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®); Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt |
| OPCABG | Active comparator | Off-pump coronary artery bypass grafting treatment which is performed with a help of Starfish®, Octopus®, Clearview® blower, ClearView® Shunt.
(OPCABG group, n=50) Receives: Procedure: OPCABG; Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt |
| ONCABG | Active comparator | On-pump coronary artery bypass grafting treatment (ONCABG group, n=50) Receives: Procedure: ONCABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Major adverse cardiac and cerebral events (MACCE), including death, a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events:
Death from any cause. From cardiovascular causes. From noncardiovascular causes.
Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.
Measured: up to 3 years
Secondary outcomes (9)
Procedural success
Procedural success: The MICS CABG treatment will be considered successful when a complete or functionally reasonable revascularisation in the absence of complications during the index hospitalization has been achieved.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Transfusion rate
Proportion of patients who received at least one transfusion of any blood product
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Recovery time
Length of postoperative hospital stay from the end of the intervention up to discharge from the hospital
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
New York Heart Association (NYHA) class modification with respect to baseline
Measured: up to 3 years
Wound infection
Drainage of purulent material from the wound (superficial or deep)
Measured: up to 12 months postoperatively
New-onset renal failure
The need for temporary or permanent renal dialysis of any type
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Respiratory insufficiency
Cumulative requirement for intubation and ventilation of 72 h or more, at any time during the postoperative stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Return to full physical activity postoperatively
(1) the ability to walk 30 min or more per day and (2) the ability to use the upper torso and arms without restriction for activities of daily living
Measured: up to 3 years
Intensive care unit (ICU) stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitebsk Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aliaksandr A Ziankou, Vitebsk Regional Clinical Hospital
- Investigators
- Aliaksandr A Ziankou, MD, PhD, Principal investigator, Vitebsk Regional Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047266
- Sponsor's protocol ID
- MICSREVS
- Status last verified
- Dec 2015
- First submitted
- 19 Jan 2014
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting (MICS CABG) Versus Off Pump (OPCABG) and on Pump Coronary Artery Bypass Grafting (ONCABG) in Patients With Multi-vessel Coronary Disease
- ClinicalTrials.gov ID
- NCT02047266
- Acronym / sponsor ID
- MICSREVS
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Heart Diseases
- Keywords
- MICS CABG OPCABG ONCABG CAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vitebsk Regional Clinical HospitalOther government
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 28 Jan 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.
The purpose of this study is to compare three different revascularization strategies in patients with multi-vessel coronary disease: MICS CABG, OPCABG and ONCABG.
The study hypothesis: MICS CABG (Minimally invasive cardiac surgery coronary artery bypass grafting) has advantages in comparison with conventional off-pump (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.
Detailed description
Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:
- MICS CABG. Minimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy). (MICS CABG group, n=50).
- OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
- ONCABG. On-pump coronary artery bypass grafting treatment (ONCABG group, n=50). The endpoints: The primary endpoints will be death, MI, stroke, or new myocardial ischemia and will be target vessel revascularization and non-target vessel revascularization at 30 days, 12 months and 3-year follow-up.
The secondary endpoints: Procedural success, Procedural and post-procedural blood loss and number of transfusions, Wound complications, Recovery time, Heart Failure (New York Heart Association (NYHA)), Life quality assessed by one of the life quality questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MICS CABG | Experimental | Procedure: MICS CABG, Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®), Device: Starfish®, Octopus®, Clearview® blower, ClearView® ShuntMinimally invasive cardiac surgery coronary artery bypass grafting (complete multivessel minimally invasive off-pump revascularization via left minithoracotomy), which is performed with a help of Octopus® Nuvo, Starfish® Non-Sternotomy, ThoraTrak®, Starfish®, Octopus®, Clearview® blower, ClearView® Shunt. (MICS CABG group, n=50) |
| OPCABG | Active comparator | Procedure: OPCABG, Device: Starfish®, Octopus®, Clearview® blower, ClearView® ShuntOff-pump coronary artery bypass grafting treatment which is performed with a help of Starfish®, Octopus®, Clearview® blower, ClearView® Shunt. (OPCABG group, n=50) |
| ONCABG | Active comparator | Procedure: ONCABGOn-pump coronary artery bypass grafting treatment (ONCABG group, n=50) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Multi-vessel coronary artery disease with ≥ 70% artery stenosis (according to QCA)
- II-IV Canadian Cardiovascular Society functional class of angina
- Patients at 1 month after acute myocardial infarction
- Ability to perform either of revascularization methods (MICS CABG, OPCABG, ONCABG)
- Patients must have signed an informed consent
Key exclusion criteria (11 listed)
- Pregnancy.
- Acute coronary syndrome.
- Previous CABG.
- Severe comorbidity with high procedural risk for either of the studied strategies.
- Mental diseases which block the revascularization procedure.
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 |
|---|---|---|
| MICS CABGMinimally invasive coronary artery bypass grafting - beating heart multi-vessel procedure in which the anastomoses are performed under direct vision through a lateral left mini-thoracotomy. The left internal thoracic artery is used to graft the left anterior descending artery or circumflex artery territories. Radial artery or saphenous vein are used (Y - grafts) to graft another myocardial territories. Right internal thoracic artery can be used as free Y-graft, as in-situ graft with radial artery (extension technique) or as in-situ graft without composite technique. Right gastroepiploic artery can be used to graft right coronary artery territory. Hybrid approach (MICS CABG + PCI), parallel transfemoral extracorporeal circulation without cardioplegia and CABG from the ascending aorta are acceptable for achievement of the complete revascularization. | Procedure or surgery | MICS CABG |
| OPCABGOff-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Mechanical Devices are used for coronary artery stabilization and heart positioning. Pericardial traction sutures are used to position the heart where appropriate. Blowers and Intracoronary shunts are used routinely. Anticoagulation is obtained using sodium heparin at a dose of 2mg/kg with supplemental doses to maintain adequate heparinisation (Activated clotting time>250seconds). | Procedure or surgery | OPCABG |
| ONCABGOn-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Normothermic cardiopulmonary bypass and complex blood ante-retrograde cardioplegia are used. All patients are cannulated with an proximal aortic cannula and two-stage right atrial cannula. Extracorporeal circulation is provided by the Terumo System-1 heart-lung machine using cardiopulmonary bypass systems with physiological surfaces and opened venous reservoirs. The left internal thoracic artery is used to graft the left anterior descending artery, and radial artery or saphenous vein segments are used to graft another myocardial territories. Anticoagulation is obtained using sodium heparin at a dose of 3mg/kg (ACT, activated clotting time>450seconds). | Procedure or surgery | ONCABG |
| Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®)Octopus® Nuvo - MICS CABG tissue stabilizer available for minimally invasive procedures. It minimizes the motion of a small area of the heart while the rest of the heart continues to beat normally and allows to perform anastomosis through a small incision. Starfish® Non-Sternotomy (NS) - MICS CABG heart positioner available for minimally invasive procedures. It allows for the positioning of the beating heart through a small incision, bringing coronary targets into the operative thoracotomy window. ThoraTrak® - a reusable, stainless steel MICS thoracic retractor system for minimally invasive heart surgery with multiple interchangeable blades, which allows to harvest left internal thoracic artery and to perform anastomosis through a small left thoracotomy(Medtronic, Inc., Minneapolis, MN). | Device | MICS CABG |
| Starfish®, Octopus®, Clearview® blower, ClearView® ShuntStarfish® - heart positioner is designed to position and to hold the heart to give the surgeon easy access to the vessel requiring the bypass graft. Octopus® - tissue stabilizer minimizes / limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping of the heart and without using the heart-lung machine. ClearView® Blower is designed to improve visualization of the surgical site. An irrigation mist gently clears blood from the site, improving visualization without drying or desiccating delicate tissue. The ClearView® shunt - Intracoronary shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium (Medtronic, Inc., Minneapolis, MN) | Device | MICS CABG, OPCABG |
Primary outcome
MACCE
Time frame: up to 3 years
Major adverse cardiac and cerebral events (MACCE), including death, a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause. From cardiovascular causes. From noncardiovascular causes. Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.
9 secondary outcomes
Procedural success
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Transfusion rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Recovery time
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
New York Heart Association (NYHA) class modification with respect to baseline
Time frame: up to 3 years
Wound infection
Time frame: up to 12 months postoperatively
New-onset renal failure
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Respiratory insufficiency
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Return to full physical activity postoperatively
Time frame: up to 3 years
Intensive care unit (ICU) stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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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.
Aliaksandr A Ziankou, MD, PhD principal investigator
Vitebsk Regional Clinical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICS CABG, OPCABG and ONCABG in people with Coronary Artery Disease and Myocardial Ischemia, run by Vitebsk Regional Clinical Hospital at 1 site in Belarus.
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 5 inclusion and 11 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 22 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 1 site in Belarus. 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?
Contact Aliaksandr A Ziankou, MD, PhD (+375297106526, Zenkov_Al@rambler.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: up to 3 years). 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 22 Dec 2015.