Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05626660
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2022-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Right and Left Radial Approach in Patients Undergoing Percutaneous Coronary Procedures
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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures , is there is difference in tortuosity of the radial and subclavian arteries between both approaches ?', 'timeFrame': 'Baseline', 'description': 'To compare the incidence of tortuosity in the radial and subclavian arteries between the right vs left radial approach.\n\n.'}, {'measure': 'Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures regarding easiness of cannulation of left main coronary artery and right coronary artery tortuosity by assessing time needed for cannulation', 'timeFrame': 'baseline', 'description': 'To compare the easiness of cannulation of left main (LM ) coronary artery and right coronary artery (RCA) via the two approaches by assessing time needed by the guiding wire and catheter to reach the ostia of either the left main coronary artery and right coronary artery .'}, {'measure': 'Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures , is there is possible difference in the incidence of complications via the two approaches?', 'timeFrame': 'baseline', 'description': 'To compare the incidence of complications e.g (bleeding , pseudoaneurysm formation ,e.t.c ) between the right and left radial approaches .'}, {'measure': 'Comparison between right and left radial approach in patients undergoing percutaneous coronary Procedures regarding the incidence of crossover between right and left radial approaches and between radial and femoral approach .', 'timeFrame': 'baseline', 'description': 'To compare the incidence of crossover between right and left radial arteries and femoral approach in case of marked radial spasm .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '35911661', 'type': 'BACKGROUND', 'citation': 'Daralammouri Y, Nazzal Z, Mosleh YS, Abdulhaq HK, Khayyat ZY, Hamshary YE, Azamtta M, Ghanim A, Awwad F, Majadla S, Maree M, Hamaida J, Ismail Y. Distal Radial Artery Access in comparison to Forearm Radial Artery Access for Cardiac Catheterization: A Randomized Controlled Trial (DARFORA Trial). J Interv Cardiol. 2022 Jul 15;2022:7698583. doi: 10.1155/2022/7698583. eCollection 2022.'}, {'pmid': '28506941', 'type': 'BACKGROUND', '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': '34069701', 'type': 'BACKGROUND', 'citation': 'Lee OH, Roh JW, Im E, Cho DK, Jeong MH, Choi D, Kim Y. Feasibility and Safety of the Left Distal Radial Approach in Percutaneous Coronary Intervention for Bifurcation Lesions. J Clin Med. 2021 May 19;10(10):2204. doi: 10.3390/jcm10102204.'}, {'pmid': '34501468', 'type': 'BACKGROUND', 'citation': 'Klimek K, Swiatek M, Klocek K, Tworek M, Zwolski M, Milewski K, Janas A. Comparison of Safety and Efficiency between Tiger-2 Catheter with Right Radial Artery Access and Judkins Catheter with Left Radial Artery Access. J Clin Med. 2021 Sep 6;10(17):4020. doi: 10.3390/jcm10174020.'}, {'pmid': '19616324', 'type': 'BACKGROUND', 'citation': 'Burzotta F, Trani C, De Vita M, Crea F. A new operative classification of both anatomic vascular variants and physiopathologic conditions affecting transradial cardiovascular procedures. Int J Cardiol. 2010 Nov 5;145(1):120-2. doi: 10.1016/j.ijcard.2009.06.025. Epub 2009 Jul 17.'}, {'pmid': '19926044', 'type': 'BACKGROUND', 'citation': 'Dehghani P, Mohammad A, Bajaj R, Hong T, Suen CM, Sharieff W, Chisholm RJ, Kutryk MJ, Fam NP, Cheema AN. Mechanism and predictors of failed transradial approach for percutaneous coronary interventions. JACC Cardiovasc Interv. 2009 Nov;2(11):1057-64. doi: 10.1016/j.jcin.2009.07.014.'}, {'pmid': '32166728', 'type': 'BACKGROUND', 'citation': 'Kawamura Y, Yoshimachi F, Nakamura N, Yamamoto Y, Kudo T, Ikari Y. Impact of dedicated hemostasis device for distal radial arterial access with an adequate hemostasis protocol on radial arterial observation by ultrasound. Cardiovasc Interv Ther. 2021 Jan;36(1):104-110. doi: 10.1007/s12928-020-00656-4. Epub 2020 Mar 12.'}, {'pmid': '36335609', 'type': 'BACKGROUND', 'citation': 'Abdelazeem B, Abuelazm MT, Swed S, Gamal M, Atef M, Al-Zeftawy MA, Noori MA, Lutz A, Volgman AS. The efficacy of nitroglycerin to prevent radial artery spasm and occlusion during and after transradial catheterization: A systematic review and meta-analysis of randomized controlled trials. Clin Cardiol. 2022 Dec;45(12):1171-1183. doi: 10.1002/clc.23906. Epub 2022 Nov 6.'}, {'pmid': '35570688', 'type': 'BACKGROUND', 'citation': 'Kiemeneij F, Burzotta F, Fajadet J. Thirty years of transradial coronary interventions. EuroIntervention. 2022 May 15;18(1):19-21. doi: 10.4244/EIJ-E-22-00009. No abstract available.'}, {'pmid': '18908938', 'type': 'BACKGROUND', 'citation': 'RADNER S. Thoracal aortography by catheterization from the radial artery; preliminary report of a new technique. Acta Radiol (Stockh). 1948 Feb 28;29(2):178-80. doi: 10.3109/00016924809132437. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Our aim is to compare between right and left radial approach in patients undergoing percutaneous coronary procedures regarding feasibility and complications.', 'detailedDescription': 'The radial artery has progressively became the standard access site for percutaneous coronary procedures both diagnostic and interventional. The first trans-radial access for cardiovascular diagnostics dates to 1947.\n\nIn 1989, the first case series of 100 coronary angiographies performed through the radial access, demonstrating the safety and the fast mobilization of patients with the radial approach .\n\nThe main advantages of the radial approach are increased safety and comfort of the patients with reduction of bleeding complications and immediate post-procedure ambulation .with these advantages, current guidelines highly recommend radial access for coronary angiography and percutaneous coronary intervention.\n\nMost clinical trials focused solely on the right radial approach and rarely consider the left radial approach. Indeed, the RRA has technical obstacles related to anatomy and clinical practice like increased incidence of tortuosity of the subclavian artery and radial-ulnar artery loop with the right radial approach.\n\nMost operators use the right radial access as the left radial access increase operator discomfort during vascular access and procedure, especially in obese patients.\n\nHowever, the left radial access has potential benefits for both the patient and operator. One of which is that the left radial approach is associated with lower fluoroscopy time compared with the right radial approach.\n\nLeft radial artery as well is an appropriate alternative access for coronary catheterization with less anatomical variations like tortuosity than the right radial artery Moreover, left radial access is preferred for right handed patients because of temporary post-procedural disability caused by hemostasis process in right radial artery access Also subclavian artery tortuosity is significantly more common on the right side and is an important cause of difficult, prolonged, or failed radial procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing coronary angiography or elective PCI in assiut university heart hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • All patients presented to assiut university cardiac catheterization laboratory and eligible for radial coronary procedures (either diagnostic or interventional )\n\nExclusion Criteria:\n\n* • Patients with acute coronary syndrome.\n\n * Patients with chronic upper limb ischemia\n * Patients with AV fistula\n * Patients with severe renal impairment\n * Failure to successfully cannulate the radial artery'}, 'identificationModule': {'nctId': 'NCT05626660', 'briefTitle': 'Comparison Between Right and Left Radial Approach in Patients Undergoing Percutaneous Coronary Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Right and Left Radial Approach in Patients Undergoing Percutaneous Coronary Procedures', 'orgStudyIdInfo': {'id': 'Coronary procedures'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Right Radial Group', 'interventionNames': ['Other: Coronary angiography and percutaneous coronary intervention']}, {'label': 'Left Radial Group', 'interventionNames': ['Other: Coronary angiography and percutaneous coronary intervention']}], 'interventions': [{'name': 'Coronary angiography and percutaneous coronary intervention', 'type': 'OTHER', 'description': 'Coronary angiography and percutaneous coronary intervention via radial approach', 'armGroupLabels': ['Left Radial Group', 'Right Radial Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Kerillos Alfy Ayoub Salib', 'investigatorAffiliation': 'Assiut University'}}}}