NCT05501925

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Wujin People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	GlideSheath Slender® and conventional arterial sheath	Using the GlideSheath Slender® with the outside diameter 2.46mm
DEVICE	Conventional arterial sheath	Placement of 6 French conventional Sheath (TERUMO, Introducer II )

Timeline

• Start date: 2022-09-15
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2022-08-16
• Last updated: 2023-12-19

Locations

1 site across 1 country: China