Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT03079934
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Healing After BVS-implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the amount of tissue coverage per strut level analysis at OCT', 'timeFrame': '7 weeks', 'description': 'according to study protocol'}], 'secondaryOutcomes': [{'measure': 'amount of diameter stenosis per strut in OCT examination', 'timeFrame': '7 weeks', 'description': 'according to study protocol'}, {'measure': 'amount of diameter stenosis per strut in OCT examination', 'timeFrame': '24 months', 'description': 'according to study protocol'}, {'measure': 'healing score in OCT examination', 'timeFrame': '7 weeks', 'description': 'according to study protocol'}, {'measure': 'healing score in OCT examination', 'timeFrame': '24 months', 'description': 'according to study protocol'}, {'measure': 'proportion of malapposed and protruding struts per stent in OCT examination', 'timeFrame': '7 weeks', 'description': 'according to study protocol'}, {'measure': 'proportion of malapposed and protruding struts per stent in OCT examination', 'timeFrame': '24 months', 'description': 'according to study protocol'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioresorbable vascular scaffold', 'Optical coherence tomography', 'strut coverage', 'acute coronary syndrome'], 'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '27896843', 'type': 'RESULT', 'citation': 'Baquet M, Brenner C, Wenzler M, Eickhoff M, David J, Brunner S, Theiss H, Massberg S, Guagliumi G, Mehilli J. Impact of Clinical Presentation on Early Vascular Healing After Bioresorbable Vascular Scaffold Implantation. J Interv Cardiol. 2017 Feb;30(1):16-23. doi: 10.1111/joic.12359. Epub 2016 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of coronary artery vessel wall healing at different time points in patients undergoing implantion of bioresorbable vascular scaffold by using intravascular imaging.\n\nIn addition long-term clinical follow-ups are planned for all patients treated with Absorb in the institution', 'detailedDescription': 'OCT-guided evalutation of the coronary vessel wall, endovascular healing and bioresorbable vascular scaffolds at different time points. These results will be analysed in terms of clinical presentation, gender and age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data of patients who undergo OCT examination at different time points after BVS implantation will be analysed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* optical coherence tomography examination after BVS-implantation\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03079934', 'briefTitle': 'Vascular Healing After BVS-implantation', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'Vascular Healing After Implantation of Bioresorbable Vascular Scaffold in Different Clinical Settings and Follow-up Time Points', 'orgStudyIdInfo': {'id': 'MucC002-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Absorb-BVS', 'description': 'Bioresorbable vascular scaffold implantation', 'interventionNames': ['Device: Absorb-BVS']}], 'interventions': [{'name': 'Absorb-BVS', 'type': 'DEVICE', 'otherNames': ['Absorb'], 'description': 'BVS patients undergoing optical coherence tomography examination at follow-up', 'armGroupLabels': ['Absorb-BVS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavarian', 'country': 'Germany', 'facility': 'Munich University Clinic', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Julinda Mehilli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Munich University Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Interventional cardiology', 'investigatorFullName': 'Prof. Dr. Julinda Mehilli', 'investigatorAffiliation': 'LMU Klinikum'}}}}