Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-09 @ 5:52 PM
Study NCT ID:
NCT03563768
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-10', 'studyFirstSubmitDate': '2018-06-10', 'studyFirstSubmitQcDate': '2018-06-10', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative major bleeding (BARC≥3 grade)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Difference of operative success rate between two groups', 'timeFrame': '12 months'}, {'measure': 'Difference of incidence of all-cause death between two groups', 'timeFrame': '12 months'}, {'measure': 'Difference of incidence of myocardial infarction between two groups', 'timeFrame': '12 months'}, {'measure': 'Difference of incidence of rupture of aorta between two groups', 'timeFrame': '12 months'}, {'measure': 'Difference of incidence of bleeding events (BARC 2 grade) between two groups', 'timeFrame': '12 months'}, {'measure': 'Difference of incidence of pseudoaneurysm between two groups', 'timeFrame': '12 months'}, {'measure': 'Difference of incidence of Stent thrombosis between two groups', 'timeFrame': '12 months'}, {'measure': 'Composite of average in-patient time and average cost during hospitalization', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'aortic atherosclerotic disease', 'one-stop', 'endovascular aortic repair', 'percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease', 'Aortic Atherosclerotic Disease']}, 'descriptionModule': {'briefSummary': 'The study is a prospective, randomized, controlled, exploratory trail to evaluate the strategy of "one-stop" endovascular treatment for concomitant coronary artery disease and aortic atherosclerotic disease.', 'detailedDescription': '60 patients will be allocated randomly in a 1:1 ratio into one-stop strategy group or staging strategy group. In one-stop strategy group, percutaneous coronary intervention (PCI) will be performed on the same operating room immediately after the endovascular aortic repair (EVAR); In staging strategy group, PCI will be performed several days after EVAR. The safety and effectiveness will be assessed between two groups 1 year after the operation. The economic index will be evaluated as well as.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 18 years to 75years, male or female;\n* Aortic atherosclerotic disease with indication of EVAR;\n* Coronary heart disease with indication of PCI;\n* Provided informed consent.\n\nExclusion Criteria:\n\n* Acute aortic dissection\n* Acute coronary syndrome\n* Dysfunction of coagulation system\n* Patients with gastrointestinal hemorrhage\n* Known allergy to contrasts or antiplatelet drugs\n* Renal dysfunction (GFR≤60ml/min)\n* Patient with multi-branch coronary preferred CABG'}, 'identificationModule': {'nctId': 'NCT03563768', 'briefTitle': 'Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Evaluation of the Strategy of "One-stop" Endovascular Treatment for Concomitant Coronary Artery Disease and Aortic Atherosclerotic Disease', 'orgStudyIdInfo': {'id': '2018-2-4032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One-stop strategy group', 'description': 'Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)', 'interventionNames': ['Procedure: One-stop strategy group']}, {'type': 'NO_INTERVENTION', 'label': 'Staging strategy group', 'description': 'PCI will be performed several days after EVAR'}], 'interventions': [{'name': 'One-stop strategy group', 'type': 'PROCEDURE', 'description': 'Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)', 'armGroupLabels': ['One-stop strategy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Min Yang, MD', 'role': 'CONTACT', 'email': '13810727489@163.com', 'phone': '00861088396173'}, {'name': 'Kuo Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'kzhang23@outlook.com', 'phone': '008618813019602'}], 'overallOfficials': [{'name': 'Yi-Da Tang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Yi-Da Tang', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}