Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-28 @ 8:12 AM
Study NCT ID:
NCT02026466
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-31', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Status', 'timeFrame': 'One year', 'description': 'Quantify the baseline health status effects of CTO among patients selected for CTO-PCI and quantify the changes associated with CTO-PCI using the Hybrid Approach.'}], 'secondaryOutcomes': [{'measure': 'Safety and Effectiveness', 'timeFrame': 'One Year', 'description': 'Describe safety and effectiveness among patients receiving CTO-PCI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Chronic Total Occlusion'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '22516392', 'type': 'RESULT', 'citation': 'Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.'}, {'pmid': '31185735', 'type': 'DERIVED', 'citation': 'Hirai T, Qintar M, Grantham JA, Sapontis J, Cohen DJ, Lombardi W, Karmpaliotis D, Moses J, Nicholson WJ, Nugent K, Gosch KL, Spertus JA, Salisbury AC. Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Qual Outcomes. 2019 Jun;12(6):e005287. doi: 10.1161/CIRCOUTCOMES.118.005287. Epub 2019 Jun 12.'}, {'pmid': '30878475', 'type': 'DERIVED', 'citation': 'Yeh RW, Tamez H, Secemsky EA, Grantham JA, Sapontis J, Spertus JA, Cohen DJ, Nicholson WJ, Gosch K, Jones PG, Valsdottir LR, Bruckel J, Lombardi WL, Jaffer FA. Depression and Angina Among Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention: The OPEN-CTO Registry. JACC Cardiovasc Interv. 2019 Apr 8;12(7):651-658. doi: 10.1016/j.jcin.2018.12.029. Epub 2019 Mar 13.'}]}, 'descriptionModule': {'briefSummary': "This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies and procedures. The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.", 'detailedDescription': "* 1,000 participants will be enrolled into the OPEN CTO study.\n* Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.\n* Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.\n* Participants will be screened for Eligibility, and Informed Consent will be obtained.\n* Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.\n* Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.\n* Participants will undergo a Baseline interview.\n* These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.\n* Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18 or older with CAD and at least one chronic total occluded vessel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.\n* Subject is ≥ 18 years of age at the time of consent.\n\nExclusion Criteria:\n\n* The CTO segment is in a graft\n* Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.\n* Non-English speaking\n* Too hard of hearing to do follow-up by telephone.\n* Previously enrolled in OPEN CTO Registry\n* Currently a prisoner\n* Dementia\n* Subjects with no way contact by telephone for follow-up.'}, 'identificationModule': {'nctId': 'NCT02026466', 'acronym': 'OPEN-CTO', 'briefTitle': 'Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion', 'organization': {'class': 'OTHER', 'fullName': "Saint Luke's Health System"}, 'officialTitle': 'Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)', 'orgStudyIdInfo': {'id': 'OPEN CTO V1.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAD with CTO', 'description': 'Subjects will have Coronary Artery Disease with a diagnosed Chronic Total Occlusion: a coronary artery with TIMI flow of zero(no flow) for at least three months.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Heart Hospital', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Medical Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Boone Hospital Center', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Presbyterian Health System Hospital', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '94777', 'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'Peace Health Sacred Heart River Bend Medical Center', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '17405', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'York Hospital', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '91895', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'J. Aaron Grantham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint Luke's Health System"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint Luke's Health System", 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}