Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-04 @ 10:02 AM
Study NCT ID:
NCT02162056
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2014-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2014-06-07', 'studyFirstSubmitQcDate': '2014-06-11', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Ischemic Heart Disease', 'Stable Angina', 'Unstable Angina', 'Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '30658574', 'type': 'RESULT', 'citation': 'Reichart C, Wohrle J, Markovic S, Rottbauer W, Seeger J. Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique. BMC Cardiovasc Disord. 2019 Jan 18;19(1):22. doi: 10.1186/s12872-018-0994-y.'}, {'pmid': '28568564', 'type': 'DERIVED', 'citation': 'Markovic S, Kugler C, Rottbauer W, Wohrle J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J Interv Cardiol. 2017 Aug;30(4):325-330. doi: 10.1111/joic.12392. Epub 2017 Jun 1.'}, {'pmid': '27244371', 'type': 'DERIVED', 'citation': 'Markovic S, Dragomir S, Walcher D, Bernhardt P, Imhof A, Rottbauer W, Wohrle J. Clinical results of single and multiple bioresorbable drug-eluting scaffolds for treatment of de-novo coronary artery disease. Coron Artery Dis. 2016 Nov;27(7):561-5. doi: 10.1097/MCA.0000000000000392.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease', 'detailedDescription': 'Patients with coronary artery disease receive bioabsorbable vascular scaffolds. Patients are clinically followed during a period of 10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary artery disease\n* implantation of at least one bioresorbable vascular scaffold\n\nExclusion Criteria:\n\n* no written informed consent'}, 'identificationModule': {'nctId': 'NCT02162056', 'acronym': 'CSI-Ulm-BVS', 'briefTitle': 'Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold', 'orgStudyIdInfo': {'id': 'CSI-Ulm-BVS 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'use of bioresorbable vascular scaffolds', 'description': 'Implantation of bioresorbable vascular scaffold for coronary artery disease.', 'interventionNames': ['Device: use of bioresorbable vascular scaffolds']}], 'interventions': [{'name': 'use of bioresorbable vascular scaffolds', 'type': 'DEVICE', 'description': 'Implantation of bioresorbable vascular scaffolds for coronary artery disease.', 'armGroupLabels': ['use of bioresorbable vascular scaffolds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Jochen Wöhrle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm, Ulm, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Jochen Wöhrle', 'investigatorFullName': 'Jochen Wohrle', 'investigatorAffiliation': 'University of Ulm'}}}}