Coronary Heart DiseaseOPTICABGNCT02546557
Optilene® Suture for Coronary Artery Bypass Graft Surgery
An observational study of Coronary Heart Disease and Multi Vessel Coronary Artery Disease, run by Aesculap AG at 4 sites in 4 countries.
Trial summary
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Coronary Heart Disease, Multi Vessel Coronary Artery Disease
- What is being tested?
- Coronary Artery Bypass Graft surgery
- Type of treatment
- Surgery or procedure
- How many people
- 245 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 10 Nov 2015to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patients undergoing an elective primary coronary artery bypass graft surgery (CABG).
- On pump or off pump CABG surgery
- Age ≥25 years
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
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
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
Read the 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.
- Being tested
- Coronary Artery Bypass Graft surgery
- Keywords
- CABG, Coronary Artery Bypass Grafting
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass Graft surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| OPTICABG | Patients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease. Receives: Procedure: Coronary Artery Bypass Graft surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day of discharge (average 7 to 10 days)
Secondary outcomes (7)
Incidence of myocardial infarction (MI)
Measured: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Incidence of stroke
Measured: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Mortality
Measured: until day of discharge (average 7 to 10 days), 30 days and 3 months postop
Gastrointestinal bleeding
Measured: until day of discharge (average 7 to 10 days)
Incidence of renal failure
Measured: until day of discharge (average 7 to 10 days)
Anastomosis revision rate due to rebleeding
Measured: until day of discharge (average 7 to 10 days)
Other adverse events (wound infection, angina, reoperation)
Measured: until 3 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start10 Nov 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
- Investigators
- Joseph M Padró, Prof. Dr., Principal investigator, Hospitla de la Santa Creu I Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546557
- Sponsor's protocol ID
- AAG-O-H-1421
- Acronym
- OPTICABG
- Status last verified
- Jan 2019
- First submitted
- 11 Aug 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hawkes AL, Nowak M, Bidstrup B, Speare R. Outcomes of coronary artery bypass graft surgery. Vasc Health Risk Manag. 2006;2(4):477-84. doi: 10.2147/vhrm.2006.2.4.477.
PubMed 17323602Ursulescu A, Baumann P, Ferrer MT, Contino M, Romagnoni C, Antona C, Padro Fernandez JM. Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study. Ann Med Surg (Lond). 2018 Sep 15;35:13-19. doi: 10.1016/j.amsu.2018.09.005. eCollection 2018 Nov.
PubMed 30258627
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02546557
- Acronym / sponsor ID
- OPTICABG / AAG-O-H-1421
- Keywords
- CABG, Coronary Artery Bypass Grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPTICABG | – | Procedure: Coronary Artery Bypass Graft surgeryPatients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (4 listed)
- Patients undergoing an elective primary coronary artery bypass graft surgery (CABG).
- On pump or off pump CABG surgery
- Age ≥25 years
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Artery Bypass Graft surgery | Procedure or surgery | OPTICABG |
Primary outcome
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.
7 secondary outcomes
Incidence of myocardial infarction (MI)
Time frame: 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
Mortality
Time frame: 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)
Incidence of renal failure
Time frame: 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)
Other adverse events (wound infection, angina, reoperation)
Time frame: until 3 months postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Background: PubMed 17323602Hawkes AL, Nowak M, Bidstrup B, Speare R. Outcomes of coronary artery bypass graft surgery. Vasc Health Risk Manag. 2006;2(4):477-84. doi: 10.2147/vhrm.2006.2.4.477.
- Results publication: PubMed 30258627Ursulescu A, Baumann P, Ferrer MT, Contino M, Romagnoni C, Antona C, Padro Fernandez JM. Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study. Ann Med Surg (Lond). 2018 Sep 15;35:13-19. doi: 10.1016/j.amsu.2018.09.005. eCollection 2018 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Padró, Prof. Dr. principal investigator
Hospitla de la Santa Creu I Sant Pau
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Multi Vessel Coronary Artery Disease, run by Aesculap AG at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative CABG adverse events in hospital (time frame: day of discharge (average 7 to 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546557, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.