Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-09 @ 3:58 PM
Study NCT ID:
NCT02546557
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2015-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optilene® Suture for Coronary Artery Bypass Graft Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001026', 'term': 'Coronary Artery Bypass'}], 'ancestors': [{'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-21', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Repeat Revascularization', 'timeFrame': 'until 1 and 3 months postop', 'description': 'Incidence of repeat revascularization leading to CABG or Percutaneous Coronary Intervention (PCI)'}, {'measure': 'Handling of the suture material', 'timeFrame': 'at time of surgery', 'description': 'Handling of the suture material using a questionnaire containing different dimension and a 5 point assessment level (Likert Scale)'}, {'measure': 'Length of the postoperative hospital stay', 'timeFrame': 'Until discharge (average 7 to 10 days)'}, {'measure': 'Improvement of Quality of life Score (EQ-5D-5L)', 'timeFrame': '3 months postop'}], 'primaryOutcomes': [{'measure': 'postoperative CABG adverse events in hospital', 'timeFrame': 'day of discharge (average 7 to 10 days)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of myocardial infarction (MI)', 'timeFrame': 'until day of discharge (average 7 to 10 days), 30 days and 3 months postop'}, {'measure': 'Incidence of stroke', 'timeFrame': 'until day of discharge (average 7 to 10 days), 30 days and 3 months postop'}, {'measure': 'Mortality', 'timeFrame': 'until day of discharge (average 7 to 10 days), 30 days and 3 months postop'}, {'measure': 'Gastrointestinal bleeding', 'timeFrame': 'until day of discharge (average 7 to 10 days)'}, {'measure': 'Incidence of renal failure', 'timeFrame': 'until day of discharge (average 7 to 10 days)'}, {'measure': 'Anastomosis revision rate due to rebleeding', 'timeFrame': 'until day of discharge (average 7 to 10 days)'}, {'measure': 'Other adverse events (wound infection, angina, reoperation)', 'timeFrame': 'until 3 months postop'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CABG', 'Coronary Artery Bypass Grafting'], 'conditions': ['Coronary Heart Disease', 'Multi Vessel Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '17323602', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30258627', 'type': 'RESULT', 'citation': 'Ursulescu 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.'}]}, 'descriptionModule': {'briefSummary': 'The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an elective primary coronary artery bypass graft surgery (CABG).\n* On pump or off pump CABG surgery\n* Age ≥25 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Insulin dependent Diabetes Mellitus\n* Acute myocardial infarction with Creatinine Kinase-MB level \\> 10% of CK and /or ECG signs\n* Known immunodeficiency or immunosuppression\n* Other combined aortic valve intervention except cardiac valve or mitral valve surgery\n* Participation or planned participation in another cardiovascular study before study follow-up is completed.\n* Inability to give informed consent due to mental condition, mental retardation, or language barrier.'}, 'identificationModule': {'nctId': 'NCT02546557', 'acronym': 'OPTICABG', 'briefTitle': 'Optilene® Suture for Coronary Artery Bypass Graft Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Assessment of the Performance of a New Suture Material (Optilene® Suture) for Coronary Artery Bypass Graft Surgery. An Observational Post CE-mark Study', 'orgStudyIdInfo': {'id': 'AAG-O-H-1421'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OPTICABG', 'description': 'Patients undergoing a coronary artery bypass graft surgery for the repair of a multi-vessel disease or left main-coronary disease.', 'interventionNames': ['Procedure: Coronary Artery Bypass Graft surgery']}], 'interventions': [{'name': 'Coronary Artery Bypass Graft surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['OPTICABG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert Bosch KH Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'Sacco Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Joseph M Padró, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitla de la Santa Creu I Sant Pau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}