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

Coronary Artery Disease Clinical Trial

— SMART  

Official title:

GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Incidence of Distal Radial Artery Occlusion in Cardiovascular Intervention Via Distal Radial Artery (SMART)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501925
• Other study ID #: WJH20220731
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: December 2023
• Source: Wujin People's Hospital
• Contact: Gaojun Cai, Dr.
• Phone: 086-0519-85579193
• Email: cgj982[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 Slender® 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age = 18 years

• Palpable distal radial and conventional radial artery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Device:
• 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 )

Locations

Country	Name	City	State
China	Changzhou Wujin People's Hospital	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wujin People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of radial artery occlusion	The rate of radial artery occlusion is evaluated by ultrasound	24 hours after the coronary angiography or intervention
Secondary	Pain during the placement of the sheath	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
Secondary	Radial artery dissection	The incidence of dissection of the radial artery is evaluated by ultrasound	24 hours after the coronary angiography or intervention
Secondary	Time of hemostasis	The time from the compress to hemostasis	24 hours after the coronary angiography or intervention
Secondary	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