OPTICABG: Optilene® Suture for Coronary Artery Bypass Graft Surgery

Sponsor

Aesculap AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02546557

Collaborator

B.Braun Surgical SA (Industry)

245

Enrollment

Locations

34.7

Actual Duration (Months)

61.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Multi Vessel Coronary Artery Disease	Procedure: Coronary Artery Bypass Graft surgery

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 Design

Study Type:

Observational

Actual Enrollment :

245 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 10, 2015

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
OPTICABG 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

Arm

Intervention/Treatment

OPTICABG

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Repeat Revascularization [until 1 and 3 months postop]
Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)
Handling of the suture material [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 [Until discharge (average 7 to 10 days)]
Improvement of Quality of life Score (EQ-5D-5L) [3 months postop]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Robert Bosch KH Stuttgart	Stuttgart	Germany	70376
2	Sacco Hospital	Milano	Italy	20157
3	Hospital de Santa Maria	Lisboa	Portugal	1649-035
4	Hospital de la Santa Creu I Sant Pau	Barcelona	Spain	08026