Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-29 @ 10:42 AM
Study NCT ID:
NCT01012869
Status:
COMPLETED
Last Update Posted:
2013-10-29
First Post:
2009-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054059', 'term': 'Coronary Occlusion'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-28', 'studyFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-stent binary angiographic restenosis rate', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'In-stent neointimal hyperplasia, as assessed by intravascular ultrasonography', 'timeFrame': '8 months'}, {'measure': 'Percent stent strut coverage, as assessed by optical coherence tomography', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary chronic total occlusions'], 'conditions': ['Coronary Occlusions']}, 'referencesModule': {'references': [{'pmid': '26332874', 'type': 'DERIVED', 'citation': 'Kotsia A, Navara R, Michael TT, Sherbet DP, Roesle M, Christopoulos G, Rangan BV, Haagen D, Garcia S, Maniu C, Pershad A, Abdullah SM, Hastings JL, Kumbhani DJ, Luna M, Addo T, Banerjee S, Brilakis ES. The AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusion (ACE-CTO) Study. J Invasive Cardiol. 2015 Sep;27(9):393-400.'}]}, 'descriptionModule': {'briefSummary': 'Chronically total occlusions (CTO) are difficult to treat and have high risk for restenosis. Although everolimus-eluting stents (EES) \\[(Xience, Abbott Vascular) or Promus (Boston Scientific)\\] are very promising for the treatment of CTOs due to their low late loss and excellent deliverability, there are currently no published data on EES implantation in CTOs.\n\nThe specific aim of this proposal is to examine the 8-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of \\> 50% of the minimum lumen diameter of the target stent) after implantation of the EES in CTO.\n\nIt is the investigators hypothesis that EES-treated CTO lesions will have ≤ 20% 8-month in-stent binary angiographic restenosis rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years old\n2. Successful treatment of a native coronary artery CTO (defined as a lesion with 100% angiographic stenosis that is at least 3 months old as estimated by clinical information, sequential angiographic information, or both) using everolimus-eluting stents\n3. Able and willing to return for angiographic follow-up after 8 months and to be followed clinically for 12 months\n4. Agree to participate and provide informed consent\n\nExclusion Criteria:\n\n1. Planned non-cardiac surgery within the following 12 months\n2. Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy\n3. Coexisting conditions that limit life expectancy to less than 12 months\n4. Patients who have a creatinine above 2.5 mg/dL (unless they require hemodialysis, in which case they are eligible to participate)\n5. History of an allergic reaction or significant sensitivity to everolimus'}, 'identificationModule': {'nctId': 'NCT01012869', 'acronym': 'ACE-CTO', 'briefTitle': 'AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study', 'organization': {'class': 'FED', 'fullName': 'North Texas Veterans Healthcare System'}, 'officialTitle': 'AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions - the ACE-CTO Study', 'orgStudyIdInfo': {'id': '09-070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'everolimus-eluting stent', 'description': 'patients undergoing treatment of a coronary chronic total occlusion (at least 3-months old) using everolimus-eluting stents (Xience, Abbott Vascular) or Promus (Boston Scientific)', 'interventionNames': ['Device: everolimus-eluting stent']}], 'interventions': [{'name': 'everolimus-eluting stent', 'type': 'DEVICE', 'description': 'everolimus-eluting stent (Xience, Abbott Vascular) or Promus (Boston Scientific)', 'armGroupLabels': ['everolimus-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas VA Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Emmanouil S Brilakis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Texas Veterans Healthcare System'}, {'name': 'Subhash Banerjee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'North Texas Veterans Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Texas Veterans Healthcare System', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Emmanouil S. Brilakis, MD, PhD', 'oldOrganization': 'VA North Texas Healthcare System'}}}}