NCT02546557

Optilene® Suture for Coronary Artery Bypass Graft Surgery

Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 245 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease
• Multi Vessel Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Coronary Artery Bypass Graft surgery

Timeline

• Start date: 2015-11-10
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2015-09-11
• Last updated: 2019-01-23

Locations

4 sites across 4 countries: Germany, Italy, Portugal, Spain