Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-26 @ 5:27 PM
Study NCT ID:
NCT01776567
Status:
UNKNOWN
Last Update Posted:
2014-08-05
First Post:
2012-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-02', 'studyFirstSubmitDate': '2012-08-11', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation', 'timeFrame': 'Immediately following stent deployment'}], 'secondaryOutcomes': [{'measure': 'Percentage of uncovered stent struts', 'timeFrame': '6 mths post initial PCI procedure'}, {'measure': 'Mean neointimal tissue thickness (microns)', 'timeFrame': '6 months post initial PCI Procedure'}, {'measure': 'Stent length (mm) measured using OCT', 'timeFrame': '6 months post initial PCI procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'stents', 'optical imaging'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography.\n\nHypotheses:\n\n1. The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT.\n2. Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction\n3. Presence of one or more coronary artery stenosis \\> 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.25 mm which can be covered with one or multiple stents\n4. No limitation to the number of treated lesions or number of vessels according to the randomization group\n5. De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions \\> 3 months, lesions \\> 20mm in length or moderately/heavily calcified lesions of any length\n\nExclusion Criteria:\n\n1. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material\n2. Acute ST-segment elevation myocardial infarction\n3. Type A lesion including vessel angulation \\<45 degrees\n4. Bypass graft\n5. Inability to provide informed consent\n6. Pregnancy\n7. Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period\n8. Left ventricular ejection fraction \\< 25%\n9. Serum creatinine \\> 180mmol/L'}, 'identificationModule': {'nctId': 'NCT01776567', 'acronym': 'APPOSE', 'briefTitle': 'Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms', 'organization': {'class': 'OTHER', 'fullName': 'Northern Hospital, Australia'}, 'officialTitle': 'Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.', 'orgStudyIdInfo': {'id': '01/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cobalt Chromium Everolimus-eluting stent (Xience Prime)', 'description': 'Cobalt Chromium Everolimus-eluting stent (Xience Prime)', 'interventionNames': ['Device: Everolimus eluting stents']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Platinum Chromium Everolimus-eluting stent (Promus Element)', 'description': 'Platinum Chromium Everolimus-eluting stent (Promus Element)', 'interventionNames': ['Device: Everolimus eluting stents']}], 'interventions': [{'name': 'Everolimus eluting stents', 'type': 'DEVICE', 'armGroupLabels': ['Cobalt Chromium Everolimus-eluting stent (Xience Prime)', 'Platinum Chromium Everolimus-eluting stent (Promus Element)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Concord', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Harry Lowe', 'role': 'CONTACT'}, {'name': 'Harry Lowe', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Concord Repatriation Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'city': 'Brisbane', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Darren Walters', 'role': 'CONTACT'}, {'name': 'Darren Walters', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Prince Charles Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3076', 'city': 'Epping', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rita Wong', 'role': 'CONTACT', 'email': 'rita.wong@nh.org.au'}, {'name': 'Peter Barlis, MBBS PHD FRACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northern Hospital', 'geoPoint': {'lat': -37.65, 'lon': 145.03333}}, {'zip': '3065', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Robert Whitbourn', 'role': 'CONTACT'}, {'name': 'Robert Whitbourn', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Peter Barlis, MBBS MPH PHD FESC FRACP', 'role': 'CONTACT', 'email': 'pbarlis@unimelb.edu.au', 'phone': '+61 3 8405 8554'}], 'overallOfficials': [{'name': 'Peter Barlis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Hospital, Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interventional Cardiologist', 'investigatorFullName': 'A/Prof. Peter Barlis', 'investigatorAffiliation': 'Northern Hospital, Australia'}}}}