An observational study in Coronary Heart Disease and Multi Vessel Coronary Artery Disease, sponsored by Aesculap AG. Completed at 4 sites in 4 countries. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2019-01-23.
Sponsored by Aesculap AG · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 245 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
adult patients
Exclusion Criteria:
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
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)
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
Repeat Revascularization
Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)
Time frame: until 1 and 3 months postop
Handling of the suture material
Handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale)
Time frame: at time of surgery
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
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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