Optilene® Suture for Coronary Artery Bypass Graft Surgery (OPTICABG)

January 21, 2019 updated by: Aesculap AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany, 70376
        • Robert Bosch KH Stuttgart
  • Italy
      • Milano, Italy, 20157
        • Sacco Hospital
  • Portugal
      • Lisboa, Portugal, 1649-035
        • Hospital De Santa Maria
  • Spain
      • Barcelona, Spain, 08026
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative CABG adverse events in hospital
Time Frame: 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.
day of discharge (average 7 to 10 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of myocardial infarction (MI)
Time Frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Incidence of stroke
Time Frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
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
until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Gastrointestinal bleeding
Time Frame: until day of discharge (average 7 to 10 days)
until day of discharge (average 7 to 10 days)
Incidence of renal failure
Time Frame: until day of discharge (average 7 to 10 days)
until day of discharge (average 7 to 10 days)
Anastomosis revision rate due to rebleeding
Time Frame: until day of discharge (average 7 to 10 days)
until day of discharge (average 7 to 10 days)
Other adverse events (wound infection, angina, reoperation)
Time Frame: until 3 months postop
until 3 months postop

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeat Revascularization
Time Frame: until 1 and 3 months postop
Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)
until 1 and 3 months postop
Handling of the suture material
Time Frame: at time of surgery
Handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale)
at time of surgery
Length of the postoperative hospital stay
Time Frame: Until discharge (average 7 to 10 days)
Until discharge (average 7 to 10 days)
Improvement of Quality of life Score (EQ-5D-5L)
Time Frame: 3 months postop
3 months postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Investigators

  • Principal Investigator: Joseph M Padró, Prof. Dr., Hospitla de la Santa Creu I Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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