Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05963620
Status:
UNKNOWN
Last Update Posted:
2023-07-27
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': 'approximately 15 years after procedure', 'description': 'further categorized into cardiovascular, noncardiovascular, and undetermined deaths'}], 'secondaryOutcomes': [{'measure': 'composite secondary endpoint', 'timeFrame': 'approximately 15 years after procedure', 'description': 'all-cause death, myocardial infarction or repeat target vessel revascularization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'sirolimus-eluting stent', 'coronary artery bypass grafting'], 'conditions': ['Coronary Stenosis', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease.\n\nThe purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population.', 'detailedDescription': 'The randomized multicenter, open-label trial "Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis" was conducted at 4 tertiary care centers in Germany. 201 patients with unprotected left main stem stenosis (≥50%) with or without additional multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/\n\nLong-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation. Wherever possible, data will be completed and verified by health care records. Retrospective data of the underlying randomized study will be included in data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'participants of the preceding study: Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alive participants of underlying study who give their consent to participate\n* deceased participants of underlying study\n\nExclusion Criteria:\n\n* alive participants of underlying study who do not consent'}, 'identificationModule': {'nctId': 'NCT05963620', 'briefTitle': 'Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center Leipzig - University Hospital'}, 'officialTitle': 'Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease', 'orgStudyIdInfo': {'id': '2021-0444'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'percutaneous coronary intervention (PCI)', 'description': 'percutaneous coronary intervention (PCI) with sirolimus-eluting stents', 'interventionNames': ['Other: percutaneous coronary intervention vs bypass graft surgery']}, {'label': 'coronary artery bypass grafting (CABG)', 'description': 'coronary artery bypass graft surgery', 'interventionNames': ['Other: percutaneous coronary intervention vs bypass graft surgery']}], 'interventions': [{'name': 'percutaneous coronary intervention vs bypass graft surgery', 'type': 'OTHER', 'description': 'retrieve long term follow up data on clinical outcome of study population, no intervention', 'armGroupLabels': ['coronary artery bypass grafting (CABG)', 'percutaneous coronary intervention (PCI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79189', 'city': 'Bad Krozingen', 'state': 'Baden Würtemberg', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '80336', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum der Ludwig-Maximilians Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81737', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'München Klinik Neuperlach', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Heart Center Leipzig at University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Steffen Desch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Center Leipzig at University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Center Leipzig - University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}