Optilene® Suture for Coronary Artery Bypass Graft Surgery

Coronary Heart Disease Clinical Trial

— OPTICABG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546557
• Other study ID #: AAG-O-H-1421
• Status: Completed
• Start date: November 10, 2015
• Est. completion date: October 2018

Study information

• Verified date: January 2019
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Multi Vessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary Artery Bypass Graft surgery

Locations

Country	Name	City	State
Germany	Robert Bosch KH Stuttgart	Stuttgart
Italy	Sacco Hospital	Milano
Portugal	Hospital de Santa Maria	Lisboa
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Spain, 

References & Publications (2)

Hawkes AL, Nowak M, Bidstrup B, Speare R. Outcomes of coronary artery bypass graft surgery. Vasc Health Risk Manag. 2006;2(4):477-84. Review. — View Citation

Ursulescu A, Baumann P, Ferrer MT, Contino M, Romagnoni C, Antona C, Padró Fernández JM. Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study. Ann Med S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Repeat Revascularization	Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)	until 1 and 3 months postop
Other	Handling of the suture material	Handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale)	at time of surgery
Other	Length of the postoperative hospital stay		Until discharge (average 7 to 10 days)
Other	Improvement of Quality of life Score (EQ-5D-5L)		3 months postop
Primary	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.	day of discharge (average 7 to 10 days)
Secondary	Incidence of myocardial infarction (MI)		until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Secondary	Incidence of stroke		until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Secondary	Mortality		until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Secondary	Gastrointestinal bleeding		until day of discharge (average 7 to 10 days)
Secondary	Incidence of renal failure		until day of discharge (average 7 to 10 days)
Secondary	Anastomosis revision rate due to rebleeding		until day of discharge (average 7 to 10 days)
Secondary	Other adverse events (wound infection, angina, reoperation)		until 3 months postop