Optilene® Suture for Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.

Detailed Description
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Coronary artery bypass graft (CABG) surgery is one of the most common elective surgical procedure. In total 40.000 CABG´s have been performed yearly in Germany in 2012 and 2013 which presents 60% of all cardiac surgical interventions. Coronary artery bypass grafting is performed for patients with coronary artery disease (CAD) to improve quality of life and to reduce cardiac-related mortality. CAD is the most leading cause of mortality in the Western world as well as in developing countries and it is the most common cause of heart failure. CABG was introduced in the 1960s. CABG operation has become the most studied intervention in the history of surgery. It is highly effective in the treatment of severe angina and it delays unfavorable events such as death, myocardial infarction and recurrence of angina in comparison to other treatment forms. There is a general agreement that already in the early postoperative period CABG surgery improves the disease in patients with symptomatic left main coronary artery stenosis or stenosis of the three main coronary vessels.

Official Title
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Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study

Conditions
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Coronary Heart Disease, Multi Vessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary Artery Bypass Graft surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an elective primary coronary artery bypass graft surgery (CABG). On pump or off pump CABG surgery Age ≥25 years Written informed consent Exclusion Criteria: Emergency surgery Insulin dependent Diabetes Mellitus Acute myocardial infarction with Creatinine Kinase-MB level > 10% of CK and /or ECG signs Known immunodeficiency or immunosuppression Other combined aortic valve intervention except cardiac valve or mitral valve surgery Participation or planned participation in another cardiovascular study before study follow-up is completed. Inability to give informed consent due to mental condition, mental retardation, or language barrier.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OPTICABG<br>Patients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease. | Procedure: Coronary Artery Bypass Graft surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative CABG adverse events in hospital | Incidence of individual postoperative CABG adverse events in hospital. Postoperative CABG adverse events are defined as the sum of the frequency of myocardial infarction, stroke, mortality, renal failure and gastrointestinal bleeding. | day of discharge (average 7 to 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myocardial infarction (MI) |  | until day of discharge (average 7 to 10 days), 30 days and 3 months postop | 
| Incidence of stroke |  | until day of discharge (average 7 to 10 days), 30 days and 3 months postop | 
| Mortality |  | until day of discharge (average 7 to 10 days), 30 days and 3 months postop | 
| Gastrointestinal bleeding |  | until day of discharge (average 7 to 10 days) | 
| Incidence of renal failure |  | until day of discharge (average 7 to 10 days) | 
| Anastomosis revision rate due to rebleeding |  | until day of discharge (average 7 to 10 days) | 
| Other adverse events (wound infection, angina, reoperation) |  | until 3 months postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Coronary Artery Bypass Grafting