Clinical trial NCT02546557: Optilene® Suture for Coronary Artery Bypass Graft Surgery
Official title: Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Multi Vessel Coronary Artery Disease
Keywords: CABG
Coronary Artery Bypass Grafting
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2015-09-11
Enrollment: 245
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative CABG adverse events in hospital
timeFrame: day of discharge (average 7 to 10 days)
Secondary outcomes:
measure: Incidence of myocardial infarction (MI)
timeFrame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
measure: Incidence of stroke
timeFrame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
measure: Mortality
timeFrame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
measure: Gastrointestinal bleeding
timeFrame: until day of discharge (average 7 to 10 days)
measure: Incidence of renal failure
timeFrame: until day of discharge (average 7 to 10 days)
measure: Anastomosis revision rate due to rebleeding
timeFrame: until day of discharge (average 7 to 10 days)
measure: Other adverse events (wound infection, angina, reoperation)
timeFrame: until 3 months postop
Other outcomes:
measure: Repeat Revascularization
timeFrame: until 1 and 3 months postop
measure: Handling of the suture material
timeFrame: at time of surgery
measure: Length of the postoperative hospital stay
timeFrame: Until discharge (average 7 to 10 days)
measure: Improvement of Quality of life Score (EQ-5D-5L)
timeFrame: 3 months postop
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch KH Stuttgart
city: Milano
country: Italy
facility: Sacco Hospital
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
Study officials:
affiliation: Hospitla de la Santa Creu I Sant Pau
name: Joseph M Padró, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawkes AL, Nowak M, Bidstrup B, Speare R. Outcomes of coronary artery bypass graft surgery. Vasc Health Risk Manag. 2006;2(4):477-84. doi: 10.2147/vhrm.2006.2.4.477.
citation: Ursulescu A, Baumann P, Ferrer MT, Contino M, Romagnoni C, Antona C, Padro Fernandez JM. Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study. Ann Med Surg (Lond). 2018 Sep 15;35:13-19. doi: 10.1016/j.amsu.2018.09.005. eCollection 2018 Nov.