ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02546557
Date of registration:	11/08/2015
Prospective Registration:	Yes
Primary sponsor:	Aesculap AG
Public title:	Optilene® Suture for Coronary Artery Bypass Graft Surgery OPTICABG
Scientific title:	Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study
Date of first enrolment:	November 10, 2015
Target sample size:	245
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02546557
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Germany	Italy	Portugal	Spain

Contacts

Name:	Joseph M Padró, Prof. Dr.
Address:
Telephone:
Email:
Affiliation:	Hospitla de la Santa Creu I Sant Pau

Key inclusion & exclusion 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.

Age minimum: 25 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multi Vessel Coronary Artery Disease

Coronary Heart Disease

Intervention(s)

Procedure: Coronary Artery Bypass Graft surgery

Primary Outcome(s)

postoperative CABG adverse events in hospital [Time Frame: day of discharge (average 7 to 10 days)]

Secondary Outcome(s)

Incidence of myocardial infarction (MI) [Time Frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop]

Anastomosis revision rate due to rebleeding [Time Frame: until day of discharge (average 7 to 10 days)]

Incidence of stroke [Time Frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop]

Mortality [Time Frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop]

Incidence of renal failure [Time Frame: until day of discharge (average 7 to 10 days)]

Gastrointestinal bleeding [Time Frame: until day of discharge (average 7 to 10 days)]

Other adverse events (wound infection, angina, reoperation) [Time Frame: until 3 months postop]

Secondary ID(s)

AAG-O-H-1421

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

B.Braun Surgical SA

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.