Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-29 @ 3:09 AM
Study NCT ID:
NCT04444960
Status:
UNKNOWN
Last Update Posted:
2020-08-21
First Post:
2020-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Therapy in Complex High-risk Coronary Artery Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2020-06-21', 'studyFirstSubmitQcDate': '2020-06-21', 'lastUpdatePostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite ischemic events', 'timeFrame': '24 months', 'description': 'Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a prospective registry to enroll complex high-risk coronary heart disease patients.\n\nThe purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Coronary heart disease patients with complicated clinical conditions and/or complex coronary lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bifurcation lesions with branch diameter ≥2.5mm;\n* Chronic complete occlusion (occlusion duration ≥3 months);\n* Left main disease;\n* Long lesions (≥38mm);\n* Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation);\n* Multi-stent implantation (≥3 stents);\n* In-stent restenosis;\n* Moderate to severe calcification on radiography;\n* Intermediate lesion;\n* Thrombotic lesions;\n* Creatinine clearance rate \\< 60ml/min) or on dialysis ;\n* Left ventricular ejection fraction \\<40% ；\n* History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract.\n\nExclusion Criteria:\n\n* Informed consent cannot be obtained;\n* Life expectancy \\< 1 year.'}, 'identificationModule': {'nctId': 'NCT04444960', 'acronym': 'PTCA', 'briefTitle': 'Precision Therapy in Complex High-risk Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2019-014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intracoronary physiology and imaging-guided group', 'interventionNames': ['Procedure: percutaneous coronary intervention']}, {'label': 'Angiography-guided group', 'interventionNames': ['Procedure: percutaneous coronary intervention']}], 'interventions': [{'name': 'percutaneous coronary intervention', 'type': 'PROCEDURE', 'description': 'Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients', 'armGroupLabels': ['Angiography-guided group', 'Intracoronary physiology and imaging-guided group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Huang, phD', 'role': 'CONTACT', 'email': 'hearthx@126.com', 'phone': '008613571961135'}], 'facility': "First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Xin Huang, PhD', 'role': 'CONTACT', 'email': 'hearthx@126.com', 'phone': '008613571961135'}], 'overallOfficials': [{'name': 'Xin Huang, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}