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Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath SlenderĀ® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath SlenderĀ® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.
Distal transradial artery (dTRA) approach has emerged as a new approach in cardiovascular intervention in recent years. Compared to the conventional radial artery (CRA) approach, the dTRA approach dramatically reduced the risk of radial artery occlusion (RAO). In recent years, the incidence of distal radial artery occlusion (dRAO) after dTRA intervention has been reported in the literature, ranged from 0.12% to 5.2%. Outside diameter of artery sheath may affect the incidence of dRAO. Retrospective study reported that an artery/ sheath ratio > 1.0 was least damaging to the vessel during coronary intervention via dTRA. Compared with conventional artery sheath (TERUMO, Introducer II ), 6 French GlideSheath SlenderĀ® has more smaller outer-side diameter (2.46mm vs. 2.62mm). The investigators suspected that use of the GlideSheath Slender can reduce the incidence of dRAO in cardiovascular intervention via dTRA approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GlideSheath SlenderĀ® | Experimental | Placement of 6 French GlideSheath SlenderĀ® for cardiovascular intervention via distal radial artery |
|
| Conventional Sheath | Active Comparator | Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlideSheath SlenderĀ® and conventional arterial sheath | Device | Using the GlideSheath SlenderĀ® with the outside diameter 2.46mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of distal radial artery occlusion | The rate of distal radial artery occlusion is evaluated by ultrasound | 24 hours after the coronary angiography or intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of radial artery occlusion | The rate of radial artery occlusion is evaluated by ultrasound | 24 hours after the coronary angiography or intervention |
| Pain during the placement of the sheath |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaojun Cai, Dr. | Contact | 086-0519-85579193 | cgj982@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Gaojun Cai | Wujin hospital affiliated with Jiangsu University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzhou Wujin People's Hospital | Recruiting | Changzhou | Jiangsu | 213017 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28506941 | Background | 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. | |
| 34945269 | Background | 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. |
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GlideSheath SlenderĀ® group Conventional Sheath group (TERUMO, Introducer II )
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| Conventional arterial sheath | Device | Placement of 6 French conventional Sheath (TERUMO, Introducer II ) |
|
Visual analog scale is used to evaluate the pain during the placement of the sheath, which ranges from 0-10, and 0 meas no pain
| 24 hours after the coronary angiography or intervention |
| Radial artery dissection | The incidence of dissection of the radial artery is evaluated by ultrasound | 24 hours after the coronary angiography or intervention |
| Time of hemostasis | The time from the compress to hemostasis | 24 hours after the coronary angiography or intervention |
| Haematoma | The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria | 24 hours after the coronary angiography or intervention |
| 34922888 | Background | 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. |
| 34381321 | Background | 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. |
| 32758150 | Background | 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. |
| 30617776 | Background | 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. |
| 41478549 | Derived | Li F, Zhou T, Fan X, Chen T, Shi G, Li L, Cai G. Safety and Efficacy of Distal Transradial Access in Patients With Small Diameter Distal Radial Artery: A Post Hoc Analysis of 2 Randomized Trials. Can J Cardiol. 2025 Dec 30:S0828-282X(25)01616-2. doi: 10.1016/j.cjca.2025.12.048. Online ahead of print. |
| 39032557 | Derived | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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