Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05253820
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2022-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], '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': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center parallel randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 801}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-08', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long-term radial artery occlusion', 'timeFrame': '3 months after procedure', 'description': 'Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure'}], 'secondaryOutcomes': [{'measure': 'radial artery occlusion', 'timeFrame': 'at 24 hours after procedure', 'description': 'Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure'}, {'measure': 'success rate of puncture', 'timeFrame': 'at 24 hours post procedure', 'description': 'Success of puncture is defined as the sheath inserted into the artery'}, {'measure': 'time of puncture', 'timeFrame': 'at 24 hours post procedure', 'description': 'time of puncture is defined as the time from initial puncture to the sheath inserted into the artery'}, {'measure': 'Radial artery trauma', 'timeFrame': 'at 24 hours and 3 months post procedure', 'description': 'Number of participants with radial artery trauma in the radial and distal radial artery, such as the intimal tears, dissections, thrombosis, and pseudoaneurysms in the radial and distal radial artery, which is detected by ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'distal radial artery', 'conventional radial artery', 'radial artery occlusion'], 'conditions': ['Coronary Artery Disease', 'Distal Radial Artery', 'Radial Artery Occlusion']}, 'referencesModule': {'references': [{'pmid': '33932290', 'type': 'RESULT', 'citation': 'Gupta A, Agstam S. Radial Artery Pseudoaneurysm Following Percutaneous Coronary Intervention. J Invasive Cardiol. 2021 May;33(5):E406. doi: 10.25270/jic/20.00272.'}, {'pmid': '26811162', 'type': 'RESULT', 'citation': 'Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.'}, {'pmid': '34107564', 'type': 'RESULT', 'citation': 'Tehrani DM, Seto AH. Heparin, compression, and radial artery occlusion: Less is more. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1377-1378. doi: 10.1002/ccd.29764. No abstract available.'}, {'pmid': '31380781', 'type': 'RESULT', 'citation': 'Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D. Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide. EuroIntervention. 2021 Mar 19;16(16):1342-1348. doi: 10.4244/EIJ-D-19-00555.'}, {'pmid': '28506941', 'type': 'RESULT', 'citation': 'Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.'}, {'pmid': '33349158', 'type': 'RESULT', 'citation': 'Soydan E, Akin M. Applicability of left distal radial artery access site in ST-segment elevation myocardial infarction; A comparative evaluation with the conventional transfemoral approach. J Vasc Access. 2022 Jan;23(1):81-87. doi: 10.1177/1129729820983138. Epub 2020 Dec 21.'}, {'pmid': '33035178', 'type': 'RESULT', 'citation': 'Colletti G, Auslender J, De Meester A, Aminian A, Kayaert P, Ungureanu C. Feasibility and Safety of Performing Complex Coronary Interventions by Distal Radial Artery Using the Railway Sheathless Vascular System. J Invasive Cardiol. 2020 Dec;32(12):459-462. doi: 10.25270/jic/20.00201. Epub 2020 Oct 10.'}, {'pmid': '33380922', 'type': 'RESULT', 'citation': 'Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.'}, {'pmid': '34922888', 'type': 'RESULT', 'citation': 'Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.'}, {'pmid': '34626744', 'type': 'RESULT', 'citation': 'Mhanna M, Beran A, Nazir S, Al-Abdouh A, Barbarawi M, Sajdeya O, Ayesh H, Nesheiwat Z, Malhas SE, Eltahawy EA. Outcomes of distal versus conventional transradial access for coronary angiography and intervention: An updated systematic review and meta-analysis. Int J Cardiol. 2021 Dec 1;344:47-53. doi: 10.1016/j.ijcard.2021.10.003. Epub 2021 Oct 6.'}, {'pmid': '33602433', 'type': 'RESULT', 'citation': 'Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.'}, {'pmid': '33958163', 'type': 'RESULT', 'citation': 'Hamilton GW, Farouque O. Could Distal Radial Artery Access do More Than "Just" Reduce Rates of Radial Artery Occlusion? JACC Cardiovasc Interv. 2021 May 10;14(9):1042-1043. doi: 10.1016/j.jcin.2021.03.055. No abstract available.'}, {'pmid': '38331793', 'type': 'DERIVED', 'citation': 'Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.'}]}, 'descriptionModule': {'briefSummary': 'Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach', 'detailedDescription': 'Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Palpable unilateral distal radial and radial artery\n\nExclusion Criteria:\n\n* Age ≥ 90years;\n* Height≥ 185cm;\n* Cardiogenic shock;\n* Contraindications to puncture at the puncture site;\n* Inability to obtain written informed consent\n* Previous right radial or distal artery intervention'}, 'identificationModule': {'nctId': 'NCT05253820', 'acronym': 'CONDITION', 'briefTitle': 'Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)', 'organization': {'class': 'OTHER', 'fullName': "Wujin People's Hospital"}, 'officialTitle': 'Comparison of the Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal vs Conventional Radial Approach: Randomized-controlled Trial(CONDITION)', 'orgStudyIdInfo': {'id': '20220130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'distal radial approach group', 'description': 'subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach', 'interventionNames': ['Procedure: distal radial approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional radial access group', 'description': 'subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach', 'interventionNames': ['Procedure: conventional radial access']}], 'interventions': [{'name': 'distal radial approach', 'type': 'PROCEDURE', 'description': 'coronary diagnosis and intervention via distal vs conventional radial approach', 'armGroupLabels': ['distal radial approach group']}, {'name': 'conventional radial access', 'type': 'PROCEDURE', 'description': 'conventional radial access', 'armGroupLabels': ['conventional radial access group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213017', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Changzhou Wujin People's Hospital", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}], 'overallOfficials': [{'name': 'Gaojun Cai, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Cardiovascular department, Changzhou Wujin People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Wujin People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}