Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT03389503
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2017-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Left and Right Transradial Approach for CAG and PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], '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'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '1\\~3 months: Right radial approach 4\\~6 months: Left radial approach'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2017-12-27', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': 'At the end of procedure', 'description': 'Finishing coronary angiography/intervention without changing approach site'}], 'secondaryOutcomes': [{'measure': 'Puncture time', 'timeFrame': 'At the end of procedure', 'description': 'Duration from the start of local anesthesia infiltration to the insertion of sheath'}, {'measure': 'Coronary angiography time', 'timeFrame': 'At the end of procedure', 'description': 'Duration from the insertion of sheath to the end of coronary angiography'}, {'measure': 'Puncture + Coronary angiography time', 'timeFrame': 'At the end of procedure', 'description': 'Sum of puncture time and coronary angiography time'}, {'measure': 'Coronary intervention time', 'timeFrame': 'At the end of procedure', 'description': 'Duration from the end of coronary angiography to the end of coronary intervention'}, {'measure': 'Contrast amount during coronary angiography', 'timeFrame': 'At the end of procedure', 'description': 'Amount of contrast agent used during coronary angiography'}, {'measure': 'Contrast amount during coronary intervention', 'timeFrame': 'At the end of procedure', 'description': 'Amount of contrast agent used during coronary intervention'}, {'measure': 'Fluoroscopic dose, dose area product during coronary angiography', 'timeFrame': 'At the end of procedure', 'description': 'Dose area product during coronary angiography'}, {'measure': 'Fluoroscopic dose, dose area product during coronary intervention', 'timeFrame': 'At the end of procedure', 'description': 'Dose area product during coronary intervention'}, {'measure': 'Fluoroscopic time during coronary angiography', 'timeFrame': 'At the end of procedure', 'description': 'Fluoroscopic time during coronary angiography'}, {'measure': 'Fluoroscopic time during coronary intervention', 'timeFrame': 'At the end of procedure', 'description': 'Fluoroscopic time during coronary intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Access site', 'Transradial access', 'Coronary artery disease', 'Learning curve'], 'conditions': ['Coronary Artery Disease', 'Stable Angina', 'Unstable Angina', 'Non-ST Elevation Myocardial Infarction', 'ST-segment Elevation Myocardial Infarction', 'Ischemic Heart Disease Without Angina']}, 'descriptionModule': {'briefSummary': 'This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.', 'detailedDescription': 'The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).\n\nProcedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects undergoing coronary angiography via radial approach\n* Subjects undergoing coronary intervention via radial approach\n* Subjects give written informed consent\n\nExclusion Criteria:\n\n* Subjects undergoing procedure(s) other than coronary angiography or intervention\n* Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)"}, 'identificationModule': {'nctId': 'NCT03389503', 'acronym': 'COMPARE-Rad', 'briefTitle': 'Comparison of Left and Right Transradial Approach for CAG and PCI', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'CR316096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Right radial approach', 'description': 'Right radial approach for coronary angiography and coronary intervention', 'interventionNames': ['Procedure: Radial approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left radial approach', 'description': 'Left radial approach for coronary angiography and coronary intervention', 'interventionNames': ['Procedure: Radial approach']}], 'interventions': [{'name': 'Radial approach', 'type': 'PROCEDURE', 'description': 'Approach site for coronary angiography and coronary intervention', 'armGroupLabels': ['Left radial approach', 'Right radial approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Young Jin Youn', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}