Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-04 @ 6:39 PM
Study NCT ID:
NCT04748068
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radial artery occlusion', 'timeFrame': '24 hours', 'description': 'Evaluated clinically and by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Vascular access site complications', 'timeFrame': '24 hours', 'description': 'Includes: bleeding or hematoma, pseudoaneurysm, artery dissection, arteriovenous fistula, compartment syndrome of the forearm'}, {'measure': 'Radial artery spasm', 'timeFrame': '24 hours', 'description': 'Radial artery spasm'}, {'measure': 'Procedure success', 'timeFrame': '24 hours', 'description': 'completion of the planned procedure through the initially selected radial access route'}, {'measure': 'The degree of pain at the puncture site', 'timeFrame': '24 hours', 'description': 'Scored on a scale of 1-10 scoring system'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radial artery occlusion', '7-Fr radial sheath', 'Transradial Coronary Intervention'], 'conditions': ['Radial Artery Occlusion', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '26811162', 'type': 'BACKGROUND', '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': '31753298', 'type': 'BACKGROUND', 'citation': 'Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.'}, {'pmid': '27567021', 'type': 'BACKGROUND', 'citation': 'Aminian A, Iglesias JF, Van Mieghem C, Zuffi A, Ferrara A, Manih R, Dolatabadi D, Lalmand J, Saito S. First prospective multicenter experience with the 7 French Glidesheath slender for complex transradial coronary interventions. Catheter Cardiovasc Interv. 2017 May;89(6):1014-1020. doi: 10.1002/ccd.26773. Epub 2016 Aug 27.'}, {'pmid': '32863791', 'type': 'BACKGROUND', 'citation': 'Isawa T, Horie K, Honda T, Taguri M, Tada N. Slender Sheath/Guiding Catheter Combination vs. Sheathless Guiding Catheter for Acute Coronary Syndrome: A Propensity-Matched Analysis of the Two Devices. J Interv Cardiol. 2020 Aug 14;2020:8216831. doi: 10.1155/2020/8216831. eCollection 2020.'}, {'pmid': '10348538', 'type': 'BACKGROUND', 'citation': 'Saito S, Ikei H, Hosokawa G, Tanaka S. Influence of the ratio between radial artery inner diameter and sheath outer diameter on radial artery flow after transradial coronary intervention. Catheter Cardiovasc Interv. 1999 Feb;46(2):173-8. doi: 10.1002/(SICI)1522-726X(199902)46:23.0.CO;2-4.'}, {'pmid': '26839392', 'type': 'BACKGROUND', 'citation': 'Costa F, van Leeuwen MA, Daemen J, Diletti R, Kauer F, van Geuns RJ, Ligthart J, Witberg K, Zijlstra F, Valgimigli M, Van Mieghem NM. The Rotterdam Radial Access Research: Ultrasound-Based Radial Artery Evaluation for Diagnostic and Therapeutic Coronary Procedures. Circ Cardiovasc Interv. 2016 Feb;9(2):e003129. doi: 10.1161/CIRCINTERVENTIONS.115.003129.'}, {'pmid': '39077135', 'type': 'DERIVED', 'citation': 'Wang H, Wang HY, Wu SY, Yin D, Feng L, Song WH, Wang HJ, Zhu CG, Dou KF. Effect of Thin-Walled Radial Sheath for Large-Bore Access On Reducing Periprocedural Radial Artery Occlusion Following Complex PCI: The REDUCE-RAO Randomized Trial. Rev Cardiovasc Med. 2022 Sep 28;23(10):329. doi: 10.31083/j.rcm2310329. eCollection 2022 Oct.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the rate of early radial artery occlusion following 7-French(7-Fr) transradial coronary intervention using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 7-Fr radial sheath.', 'detailedDescription': 'Based on previously reported studies the rates of radial artery occlusion using a standard 7-Fr sheath is around 12%, compared to the previous studies of the Glidesheath Slender (see reference in the citations), the rate of radial artery occlusion was reported less than 5%. To prove Slender sheaths are superior to traditional ones, the sample size was estimated according to this, the class I error (α) is set as 0.05 on both sides, and the test efficiency (β) is set as 80%, then at least 248 patients are needed in each group.\n\nThis study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion between the 7-Fr Glidesheath Slender (Terumo, Japan) and the standard 7-Fr radial sheath (cordis, USA) in patients undergoing complex transradial coronary intervention.\n\nThe study will enroll patients who will undergo elective complex percutaneous coronary intervention (PCI) via 7-Fr transradial approach at Fuwai Hospital National Center for Cardiovascular Diseases.\n\nA baseline clinical vascular \\& ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.\n\nPatients will be randomized in 1:1 fashion to either receive the 7-Fr Terumo Glidesheath Slender versus the currently used 7-Fr sheath.\n\nThe standard angiogram/ PCI will be performed as per usual practice. Following the PCI, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing coronary PCI via 7-Fr transradial approach\n* Informed consent\n* the patency of radial artery confirmed by ultrasound\n\nExclusion Criteria:\n\n* The abnormal of radial artery confirmed by ultrasound\n* Previous failed radial access.\n* Known bleeding disorder or hypercoagulable condition\n* Cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT04748068', 'briefTitle': 'Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Use of Glidesheath Slender to Reduce Radial Artery Occlusion Following 7 French Transradial Coronary Intervention', 'orgStudyIdInfo': {'id': '7F Glidesheath Slender'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glidesheath Slender', 'description': 'The transradial procedure will be performed using the 7-Fr glidesheath slender (studied sheath)', 'interventionNames': ['Device: 7-Fr Glidesheath Slender']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard sheath', 'description': 'The transradial procedure will be performed using the standard 7- French radial sheath (comparator sheath)', 'interventionNames': ['Device: Cordis 7-Fr radial sheath']}], 'interventions': [{'name': '7-Fr Glidesheath Slender', 'type': 'DEVICE', 'otherNames': ['Glidesheath Slender, Terumo, Tokyo, Japan'], 'description': 'The 7 Fr Glidesheath Slender is a recently developed thin-walled radial sheath. It combines an ID of 2.46 mm, with an OD of 2.79 mm, representing thereby the thinnest 7 Fr sheath currently available on the market', 'armGroupLabels': ['Glidesheath Slender']}, {'name': 'Cordis 7-Fr radial sheath', 'type': 'DEVICE', 'description': 'Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm', 'armGroupLabels': ['Standard sheath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hao Wang, MD,PhD', 'role': 'CONTACT', 'email': 'wanghao_fuwai@126.com', 'phone': '+86-15701277767'}, {'name': 'Kefei Dou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chenggang Zhu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fuwai Hospital National Center for Cardiovascular Diseases', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hao Wang, MD,PhD', 'role': 'CONTACT', 'email': 'wanghao_fuwai@126.com', 'phone': '+86-15701277767'}], 'overallOfficials': [{'name': 'Kefei Dou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital National Center for Cardiovascular Diseases'}, {'name': 'Chenggang Zhu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital National Center for Cardiovascular Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}