Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-30 @ 5:31 AM
Study NCT ID:
NCT01297257
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
2010-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frank.van.leeuwen@medtronic.com', 'phone': '+31433566622', 'title': 'Frank van Leeuwen, M.D.', 'organization': 'Clinical Research Director'}, 'certainAgreement': {'otherDetails': 'For any publication or presentation of the Protected Materials or any portion thereof, a manuscript of the paper, abstract or other materials will be provided by Consultant to Sponsor for its approval at least sixty (60) days for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'stent implantation until hospital discharge (average 1-3 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 Resolute Integrity™ Stent Primary Stent', 'description': 'A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.', 'otherNumAtRisk': 7740, 'otherNumAffected': 0, 'seriousNumAtRisk': 7740, 'seriousNumAffected': 126}], 'seriousEvents': [{'term': 'Death', 'notes': 'All Death 0.2% (19/7740) Cardiac Death 0.2% (15/7740)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'General disorders'}, {'term': 'Major Adverse Cardiac Event', 'notes': 'Defined as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical method', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numEvents': 126, 'numAffected': 126}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numEvents': 103, 'numAffected': 103}], 'organSystem': 'Cardiac disorders'}, {'term': 'Definite/Probable Stent Thrombosis', 'notes': 'According to Academic Research Consortium (ARC) Definition for Stent Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Clinically-driven Target Lesion Revascularization', 'notes': 'Revascularization at target lesion (TL) with positive functional ischemia study/ischemic symptoms AND angiographic minimal lumen diameter stenosis \\>=50%, or revascularization of TL with diameter stenosis \\>=70% without angina/positive functional study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Delivery Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7740', 'groupId': 'OG000'}]}, {'units': 'Stents', 'counts': [{'value': '10733', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Resolute Integrity™ Stent Primary Stent', 'description': 'A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents'}], 'classes': [{'categories': [{'measurements': [{'value': '10617', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'stent implantation until hospital discharge (average 1-3 days)', 'description': 'The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.', 'unitOfMeasure': 'stents', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stents', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'In-hospital MACE (Major Adverse Cardiac Event)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7740', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Resolute Integrity™ Stent Primary Stent', 'description': 'A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'stent implantation until hospital discharge (average 1-3 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 Resolute Integrity™ Stent Primary Stent', 'description': 'A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7740'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7740'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled at 163 centres in Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012.', 'preAssignmentDetails': '7845 subjects enrolled in this study. 22 Subjects removed from database, per center request. Reasons varied per center.\n\n83 patients had very limited data available which resulted in the inability to be included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7740', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 Resolute Integrity™ Stent Primary Stent', 'description': 'A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '4058', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '3662', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Age of 20 (0.26%) patients not reported by investigators.', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age of 20 (0.26%) patients not reported by investigators', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '1858', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '5862', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender of 20 (0.26%) patients not reported by investigators', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7845}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2010-12-20', 'resultsFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2011-02-15', 'lastUpdatePostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-21', 'studyFirstPostDateStruct': {'date': '2011-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery Success', 'timeFrame': 'stent implantation until hospital discharge (average 1-3 days)', 'description': 'The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.'}], 'secondaryOutcomes': [{'measure': 'In-hospital MACE (Major Adverse Cardiac Event)', 'timeFrame': 'stent implantation until hospital discharge (average 1-3 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft that are amenable to percutaneous treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum legal age (18)\n* Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines\n* Patient has consented to participate and authorized in writing the collection and release of medical information\n\nExclusion Criteria:\n\n* Pregnancy\n* Participating in another study that interferes with study endpoints\n* Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media\n* Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated'}, 'identificationModule': {'nctId': 'NCT01297257', 'acronym': 'DELIVER', 'briefTitle': 'DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Vascular'}, 'orgStudyIdInfo': {'id': 'IP992'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stent implantation', 'type': 'DEVICE', 'description': 'Single arm, open label stent implantation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis Ziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Vascular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}