Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-02 @ 8:17 AM
Study NCT ID:
NCT02060357
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2014-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial stent coverage', 'timeFrame': '6 month', 'description': 'Endothelial coverage expressed as % of struts without coverage as measured by OCT'}], 'secondaryOutcomes': [{'measure': 'Neointimal hyperplasia', 'timeFrame': '6 month', 'description': 'Neointimal hyperplasia (mm2) as measured by OCT'}, {'measure': 'MACE', 'timeFrame': '6 months', 'description': 'death, heart failure, myocardial infarction, stroke, need for repeat revascularisation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'PCI', 'Drug eluting stent', 'OCT'], 'conditions': ['Coronary Artery Disease', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '29632674', 'type': 'DERIVED', 'citation': 'Hamshere S, Byrne A, Choudhury T, Gallagher SM, Rathod KS, Lungley J, Knight CJ, Kapur A, Jones DA, Mathur A. Randomised trial of the comparison of drug-eluting stents in patients with diabetes: OCT DES trial. Open Heart. 2018 Apr 5;5(1):e000705. doi: 10.1136/openhrt-2017-000705. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting stent (Boston Scientific), in patients with diabetes.\n\nWe plan to compare endothelial coverage and neointimal proliferation using OCT and compare this data to published results from conventional stents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known to have diabetes\n* Scheduled for percutaneous coronary intervention (PCI) with a stenosis suitable for DES implantation and OCT imaging\n* Reference vessel diameter over 2.5mm by operator assessment.\n* Able to understand and sign the written Informed Consent Form.\n* Able and willing to follow the Protocol requirements.\n\nExclusion Criteria:\n\n* Inability to consent\n* Cardiogenic shock\n* Planned use of a bare metal stent\n* LMS coronary artery disease\n* Congestive cardiac failure or low ejection fraction (LVEF \\<35%)\n* Lesions unsuitable for OCT\n* Total length of stented lesion greater than 55mm (total combination of stent lengths)\n* Age less than 18 years or age greater than 80 years\n* Planned surgical procedure ≤ 12 months post PCI procedure\n* Patient demonstrates evidence of thrombocytopenia (platelet count \\< 100,000/mm3)\n* Patients with contraindications to ASA, clopidogrel, or prasogrel\n* Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure\n* Allergy to contrast\n* Patients enrolled in another active clinical trial.\n* Potential for non-compliance towards the requirements in the study protocol.\n* Serious known concomitant disease with a life expectancy of less than one year\n* Follow-up impossible (no fixed abode, etc)\n* Patients with renal impairment (Creatinine \\>200mmol/L)\n* Subjects of childbearing potential'}, 'identificationModule': {'nctId': 'NCT02060357', 'acronym': 'OCT-DES', 'briefTitle': 'Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes', 'orgStudyIdInfo': {'id': '11/LO/0948'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resolute Integrity Stent', 'description': 'Patients will be randomised in a 1:1 ratio to receive two different types of DES', 'interventionNames': ['Device: Optical coherence tomography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Promus Stent', 'description': 'Patients will be randomised in a 1:1 ratio to receive two different types of DES', 'interventionNames': ['Device: Optical coherence tomography']}], 'interventions': [{'name': 'Optical coherence tomography', 'type': 'DEVICE', 'armGroupLabels': ['Promus Stent', 'Resolute Integrity Stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E2 9JX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'London Chest Hospital, Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Anthony Mathur, FRCP FESC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts & The London NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anthony Mathur', 'investigatorAffiliation': 'Barts & The London NHS Trust'}}}}