Optilene® Suture for Coronary Artery Bypass Graft Surgery

Aesculap AG245 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

245

Conditions

Coronary Heart Disease Multi Vessel Coronary Artery Disease

Interventions

Coronary Artery Bypass Graft surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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.

Locations (4)

Robert Bosch KH Stuttgart

Stuttgart, Germany

Sacco Hospital

Milan, Italy

Hospital de Santa Maria

Lisbon, Portugal

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Outcomes

Primary Outcomes

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.

Time frame: day of discharge (average 7 to 10 days)

Secondary Outcomes

Incidence of myocardial infarction (MI)

Time frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop

Incidence of stroke

Time frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop

Mortality

Time frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop

Gastrointestinal bleeding

Time frame: until day of discharge (average 7 to 10 days)

Incidence of renal failure

Time frame: until day of discharge (average 7 to 10 days)

Anastomosis revision rate due to rebleeding

Time frame: until day of discharge (average 7 to 10 days)

Other adverse events (wound infection, angina, reoperation)

Time frame: until 3 months postop

Data from ClinicalTrials.gov

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