GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)
NCT ID: NCT05501925
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2022-09-15
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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GlideSheath Slender®
Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery
GlideSheath Slender® and conventional arterial sheath
Using the GlideSheath Slender® with the outside diameter 2.46mm
Conventional Sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery
Conventional arterial sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II )
Interventions
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GlideSheath Slender® and conventional arterial sheath
Using the GlideSheath Slender® with the outside diameter 2.46mm
Conventional arterial sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II )
Eligibility Criteria
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Inclusion Criteria
* Palpable distal radial and conventional radial artery
Exclusion Criteria
* Height≥ 185cm
* ST-segment elevation myocardial infarction or Cardiogenic shock
* Contraindications to puncture at the puncture site
* Diameter of DRA less than 1.5mm or RAO
18 Years
90 Years
ALL
No
Sponsors
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Wujin People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Gaojun Cai
Role: STUDY_CHAIR
Wujin hospital affiliated with Jiangsu University
Locations
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Changzhou Wujin People's Hospital
Changzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Gaojun Cai, MD
Role: primary
References
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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.
Achim A, Kakonyi K, Jambrik Z, Nagy F, Toth J, Sasi V, Hausinger P, Nemes A, Varga A, Bertrand OF, Ruzsa Z. Distal Radial Artery Access for Coronary and Peripheral Procedures: A Multicenter Experience. J Clin Med. 2021 Dec 20;10(24):5974. doi: 10.3390/jcm10245974.
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.
Liang C, Han Q, Jia Y, Fan C, Qin G. Distal Transradial Access in Anatomical Snuffbox for Coronary Angiography and Intervention: An Updated Meta-Analysis. J Interv Cardiol. 2021 Jul 22;2021:7099044. doi: 10.1155/2021/7099044. eCollection 2021.
Cai G, Huang H, Li F, Shi G, Yu X, Yu L. Distal transradial access: a review of the feasibility and safety in cardiovascular angiography and intervention. BMC Cardiovasc Disord. 2020 Aug 5;20(1):356. doi: 10.1186/s12872-020-01625-8.
Naito T, Sawaoka T, Sasaki K, Iida K, Sakuraba S, Yokohama K, Sato H, Soma M, Okamura E, Harada T, Yoshimachi F. Evaluation of the diameter of the distal radial artery at the anatomical snuff box using ultrasound in Japanese patients. Cardiovasc Interv Ther. 2019 Oct;34(4):312-316. doi: 10.1007/s12928-018-00567-5. Epub 2019 Jan 7.
Lu W, Chen T, Wang H, Yang A, Li L, Shi G, Xue S, Li F, Xiao J, Gu J, Zhang L, Liang X, Li W, Cai G. Comparison of the Effect of a 6-French Glidesheath Slender and a Conventional Sheath on Distal Radial Artery Occlusion: A Randomized Controlled Trial. Can J Cardiol. 2024 Nov;40(11):2292-2300. doi: 10.1016/j.cjca.2024.07.011. Epub 2024 Jul 19.
Other Identifiers
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WJH20220731
Identifier Type: -
Identifier Source: org_study_id