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Completed

NCT Number: NCT02546557

Optilene® Suture for Coronary Artery Bypass Graft Surgery

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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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Bosch KH Stuttgart, Stuttgart, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary Artery Bypass Graft Surgery

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of myocardial infarction (MI)

    Time frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop

  2. Incidence of stroke

    Time frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop

  3. Mortality

    Time frame: until day of discharge (average 7 to 10 days), 30 days and 3 months postop

  4. Gastrointestinal bleeding

    Time frame: until day of discharge (average 7 to 10 days)

  5. Incidence of renal failure

    Time frame: until day of discharge (average 7 to 10 days)

  6. Anastomosis revision rate due to rebleeding

    Time frame: until day of discharge (average 7 to 10 days)

  7. Other adverse events (wound infection, angina, reoperation)

    Time frame: until 3 months postop

Other outcomes

  1. Repeat Revascularization

    Time frame: until 1 and 3 months postop

    Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)

  2. 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)

  3. Length of the postoperative hospital stay

    Time frame: Until discharge (average 7 to 10 days)

  4. Improvement of Quality of life Score (EQ-5D-5L)

    Time frame: 3 months postop

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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

Acronym: OPTICABG

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2015
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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