Optilene® Suture for Coronary Artery Bypass Graft Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

245 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-10

Study Completion Date

2018-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Coronary Heart Disease Multi Vessel Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OPTICABG

Patients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease.

Coronary Artery Bypass Graft surgery

Intervention Type PROCEDURE

Interventions

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Coronary Artery Bypass Graft surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No