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Trial record 75 of 174 for:    "Heart Disease" | "Heparin"

Comparative Effectiveness of the Minimally Invasive Coronary Artery Bypass Grafting

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ClinicalTrials.gov Identifier: NCT02047266
Recruitment Status : Unknown
Verified December 2015 by Aliaksandr A Ziankou, Vitebsk Regional Clinical Hospital.
Recruitment status was:  Recruiting
First Posted : January 28, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Aliaksandr A Ziankou, Vitebsk Regional Clinical Hospital

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Heart Diseases Procedure: MICS CABG Procedure: OPCABG Procedure: ONCABG Device: Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®) Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt Not Applicable

Detailed Description:

Prospective, single-center, randomized trial, intended to compare three different revascularization strategies in patients with multi-vessel coronary artery disease:

  1. 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).
  2. OPCABG. Off-pump coronary artery bypass grafting treatment (OPCABG group, n=50).
  3. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MICS CABG

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)

Procedure: MICS CABG
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.

Device: 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: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt
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)

Active Comparator: OPCABG

Off-pump coronary artery bypass grafting treatment which is performed with a help of Starfish®, Octopus®, Clearview® blower, ClearView® Shunt.

(OPCABG group, n=50)

Procedure: OPCABG
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).

Device: Starfish®, Octopus®, Clearview® blower, ClearView® Shunt
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)

Active Comparator: ONCABG
On-pump coronary artery bypass grafting treatment (ONCABG group, n=50)
Procedure: ONCABG
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).




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Procedural success [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    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.

  2. Transfusion rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Proportion of patients who received at least one transfusion of any blood product

  3. Recovery time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Length of postoperative hospital stay from the end of the intervention up to discharge from the hospital

  4. New York Heart Association (NYHA) class modification with respect to baseline [ Time Frame: up to 3 years ]
  5. Wound infection [ Time Frame: up to 12 months postoperatively ]
    Drainage of purulent material from the wound (superficial or deep)

  6. New-onset renal failure [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    The need for temporary or permanent renal dialysis of any type

  7. Respiratory insufficiency [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Cumulative requirement for intubation and ventilation of 72 h or more, at any time during the postoperative stay

  8. Return to full physical activity postoperatively [ Time Frame: up to 3 years ]
    (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

  9. Intensive care unit (ICU) stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

Other Outcome Measures:
  1. Procedural and post-procedural blood loss [ Time Frame: up to first twenty-four hours postoperatively ]
    blood loss during operation and first twenty-four hours postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047266


Contacts
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Contact: Aliaksandr A Ziankou, MD, PhD +375297106526 Zenkov_Al@rambler.ru
Contact: Mikalai G Laiko, MD +375333050458 Nikolay99@mail.ru

Locations
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Belarus
Vitebsk regional clinical hospital Recruiting
Vitebsk, Vitebsk region, Belarus, 210037
Contact: Aliaksandr A Ziankou, MD, PhD         
Contact: Mikalai G Laiko, MD    +375333050458    Nikolay99@mail.ru   
Principal Investigator: Aliaksandr A Ziankou, MD, PhD         
Sub-Investigator: Mikalai G Laiko, MD         
Sponsors and Collaborators
Vitebsk Regional Clinical Hospital
Investigators
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Principal Investigator: Aliaksandr A Ziankou, MD, PhD Vitebsk Regional Clinical Hospital

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Responsible Party: Aliaksandr A Ziankou, Chief of the cardiac surgery department of the VitebskRCH, Vitebsk Regional Clinical Hospital
ClinicalTrials.gov Identifier: NCT02047266     History of Changes
Other Study ID Numbers: MICSREVS
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Keywords provided by Aliaksandr A Ziankou, Vitebsk Regional Clinical Hospital:
MICS CABG OPCABG ONCABG CAD
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes