Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-02-02 @ 4:20 PM
Study NCT ID:
NCT02632292
Status:
TERMINATED
Last Update Posted:
2019-09-26
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'Slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-stent late lumen loss', 'timeFrame': 'Angiography 8-10 months after the index procedure'}], 'secondaryOutcomes': [{'measure': 'Device success', 'timeFrame': 'Baseline angiography', 'description': 'Attainment of \\<30% final residual stenosis following the index procedure.'}, {'measure': 'Procedure success', 'timeFrame': 'Baseline angiography', 'description': 'Device success and no periprocedural complications.'}, {'measure': 'Vasomotion', 'timeFrame': 'Angiography 8-10 months after the index procedure', 'description': 'Change in minimal lumen diameter before and after nitrate administration assessed by angiography at 8-10 months.'}, {'measure': 'In-segment late lumen loss', 'timeFrame': 'Angiography 8-10 months after the index procedure', 'description': 'Difference between the immediate post-procedure in-stent minimal lumen diameter and the in-stent minimal lumen diameter assessed by angiography at 8-10 months inside the stent or within 5 mm proximal or distal to the stent.'}, {'measure': 'Binary restenosis', 'timeFrame': 'Angiography 8-10 months after the index procedure', 'description': 'In-stent or in-segment restenosis ≥50% assessed by angiography at 8-10 months.'}, {'measure': 'Conformability', 'timeFrame': 'Angiography 8-10 months after the index procedure', 'description': 'Change in curvature and angulation between preprocedure, postprocedure, and angiographic follow-up at 8-10 months.'}, {'measure': 'Major adverse cardiac events', 'timeFrame': '12- and 24-months', 'description': 'Composite of cardiac death, myocardial infarction, scaffold/stent thrombosis, and target vessel revascularization'}, {'measure': 'Cardiac death', 'timeFrame': '12- and 24-months'}, {'measure': 'Myocardial infarction', 'timeFrame': '12- and 24-months'}, {'measure': 'Scaffold/stent thrombosis', 'timeFrame': '12- and 24-months'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12- and 24-months'}, {'measure': 'Target lesion failure', 'timeFrame': '12- and 24-months', 'description': 'Composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization'}, {'measure': 'Target vessel failure', 'timeFrame': '12- and 24-months', 'description': 'Composite of cardiac death, target vessel related myocardial infarction, clinically driven target vessel revascularization, and scaffold/stent thrombosis'}, {'measure': 'Clinical success', 'timeFrame': '12- and 24-months', 'description': 'Procedure success and no major adverse cardiac events at 12- and 24-month clinical follow-up'}, {'measure': 'Anginal status assessed by the Seattle Angina Questionnaire', 'timeFrame': '12- and 24-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, controlled, multicenter, open-label study to compare everolimus-eluting bioresorbable vascular scaffolds to everolimus-eluting stents in patients with diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinical inclusion criteria:\n\n* Age ≥18 years\n* DM type I or II based on the definitions of the American Diabetes Association\n* Angiographically proven CAD\n* Angina pectoris, equivalent symptoms, and/or positive stress test, and/or instantaneous flow reserve ≤0.86, and/or fractional flow reserve ≤0.80\n* Negative pregnancy test in women with childbearing potential\n\nAngiographic inclusion criteria:\n\n* De-novo lesion in at least one native coronary artery\n* Luminal diameter reduction 50-99% assessed by visual estimation\n* Target reference vessel diameter 2.5 - 4.0 mm\n\nClinical exclusion criteria:\n\n* Limited long-term prognosis with a life-expectancy \\<12 months\n* Contraindications to antiplatelet therapy\n* Known allergy against cobalt chrome, everolimus, or polylactic acid\n\nAngiographic exclusion criteria:\n\n* Target lesion located in the left main trunk\n* Severe calcification of the target lesion as determined by angiography\n* In-stent restenosis\n* Bifurcation lesion with planned two-stent strategy\n* Chronic total occlusion\n* Indication for CABG'}, 'identificationModule': {'nctId': 'NCT02632292', 'acronym': 'SUGAR-EVE', 'briefTitle': 'EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'EverolimuS-ElUtinG BioresorbAble VasculaR Scaffolds vErsus EVerolimus-Eluting Stents in Patients With Diabetes Mellitus', 'orgStudyIdInfo': {'id': '15-260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Absorb GT1', 'description': 'Bioresorbable everolimus-eluting scaffolds', 'interventionNames': ['Device: Absorb GT1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Promus', 'description': 'Everolimus-eluting stents', 'interventionNames': ['Device: Promus']}], 'interventions': [{'name': 'Absorb GT1', 'type': 'DEVICE', 'description': 'Bioresorbable vascular scaffold', 'armGroupLabels': ['Absorb GT1']}, {'name': 'Promus', 'type': 'DEVICE', 'description': 'Everolimus-eluting stent', 'armGroupLabels': ['Promus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, {'name': 'Kerckhoff Klinik', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Holger Thiele', 'investigatorAffiliation': 'University of Luebeck'}}}}