NCT Number: NCT02546557
Optilene® Suture for Coronary Artery Bypass Graft Surgery
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
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Notify MeKey information
Conditions
Age range
25 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Robert Bosch KH Stuttgart, Stuttgart, Germany
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
postoperative CABG adverse events in hospital
Time frame: 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 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
Other outcomes
-
Repeat Revascularization
Time frame: until 1 and 3 months postop
Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)
-
Handling of the suture material
Time frame: at time of surgery
Handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale)
-
Length of the postoperative hospital stay
Time frame: Until discharge (average 7 to 10 days)
-
Improvement of Quality of life Score (EQ-5D-5L)
Time frame: 3 months postop
Sponsors and collaborators
Lead sponsor
Aesculap AG
Industry
Collaborators
- B.Braun Surgical SA
Registry information
Official study title
Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study
Acronym: OPTICABG
Important dates
- Study start
- 2015
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Sep 11, 2015
- Registry last updated
- Jan 23, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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