Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting
1 other identifier
interventional
150
1 country
1
Brief 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 (OPCABG) and on-pump coronary artery bypass grafting (ONCABG) concerning major adverse cardiac and cerebral events (MACCE) and procedural success.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jan 2014
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 19, 2014
CompletedFirst Posted
Study publicly available on registry
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedDecember 22, 2015
December 1, 2015
2.4 years
January 19, 2014
December 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 3 years
Secondary Outcomes (9)
Procedural success
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Transfusion rate
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Recovery time
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
up to 3 years
Wound infection
up to 12 months postoperatively
- +4 more secondary outcomes
Other Outcomes (1)
Procedural and post-procedural blood loss
up to first twenty-four hours postoperatively
Study Arms (3)
MICS CABG
EXPERIMENTALMinimally 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 COMPARATOROff-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 COMPARATOROn-pump coronary artery bypass grafting treatment (ONCABG group, n=50)
Interventions
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.
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).
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 - 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® - 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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vitebsk regional clinical hospital
Vitebsk, Vitebsk Oblast, 210037, Belarus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aliaksandr A Ziankou, MD, PhD
Vitebsk Regional Clinical Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the cardiac surgery department of the VitebskRCH
Study Record Dates
First Submitted
January 19, 2014
First Posted
January 28, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2019
Last Updated
December 22, 2015
Record last verified: 2015-12