GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)

NCT05501925 | Unknown DMC

• 1 other identifier: WJH20220731
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Keywords

distal radial artery; distal radial artery occlusion; cardiovascular intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Rate of radial artery occlusion

  24 hours after the coronary angiography or intervention

• Pain during the placement of the sheath

  24 hours after the coronary angiography or intervention

• Radial artery dissection

  24 hours after the coronary angiography or intervention

• Time of hemostasis

  24 hours after the coronary angiography or intervention

• Haematoma

  24 hours after the coronary angiography or intervention

Study Arms (2)

GlideSheath Slender®

EXPERIMENTAL

Placement of 6 French GlideSheath Slender® for cardiovascular intervention via distal radial artery

Device: GlideSheath Slender® and conventional arterial sheath

Conventional Sheath

ACTIVE COMPARATOR

Placement of 6 French conventional Sheath (TERUMO, Introducer II ) for cardiovascular intervention via distal radial artery

Device: Conventional arterial sheath

Interventions

GlideSheath Slender® and conventional arterial sheath DEVICE

Using the GlideSheath Slender® with the outside diameter 2.46mm

GlideSheath Slender®

Conventional arterial sheath DEVICE

Placement of 6 French conventional Sheath (TERUMO, Introducer II )

Conventional Sheath

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Palpable distal radial and conventional radial artery

You may not qualify if:

• Age ≥ 90years
• 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

Sponsors & Collaborators

• Wujin People's Hospital: lead

Study Sites (1)

Changzhou Wujin People's Hospital

Changzhou, Jiangsu, 213017, China

RECRUITING

Related Publications (8)

• 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: 28506941 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.

  PMID: 34945269 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.

  PMID: 34922888 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.

  PMID: 34381321 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.

  PMID: 32758150 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.

  PMID: 30617776 BACKGROUND

• 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.

  PMID: 41478549 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.

  PMID: 39032557 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gaojun Cai

  Wujin hospital affiliated with Jiangsu University

  STUDY CHAIR

Central Study Contacts

Gaojun Cai, Dr.

CONTACT

086-0519-85579193; cgj982@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: GlideSheath Slender® group Conventional Sheath group (TERUMO, Introducer II )

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 16, 2022
• Study Start: September 15, 2022
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)