Optilene® Suture for Coronary Artery Bypass Graft Surgery

Completed

• Conditions: Coronary Heart Disease; Multi Vessel Coronary Artery Disease
• Interventions: Procedure: Coronary Artery Bypass Graft surgery

• Registration Number: NCT02546557
• Lead Sponsor: Aesculap AG

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Study Start: 2015-11-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OPTICABG	Coronary Artery Bypass Graft surgery	Patients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease.

Primary Outcome Measures

Name	Time	Method
postoperative CABG adverse events in hospital	day of discharge (average 7 to 10 days)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of myocardial infarction (MI)	until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Incidence of renal failure	until day of discharge (average 7 to 10 days)
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 stroke	until day of discharge (average 7 to 10 days), 30 days and 3 months postop
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

Trial Locations

Locations (4)

Hospital de la Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Robert Bosch KH Stuttgart; 🇩🇪 Stuttgart, Germany

Sacco Hospital; 🇮🇹 Milano, Italy

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal