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

Wujin People's Hospital

Status: Enrolling

Conditions: Coronary Artery Disease; Cardiovascular Diseases

Treatments: Device: GlideSheath Slender® and conventional arterial sheath; Device: Conventional arterial sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT05501925

WJH20220731

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

GlideSheath Slender®

Experimental group

Description:

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

Treatment:

Device: GlideSheath Slender® and conventional arterial sheath

Conventional Sheath

Active Comparator group

Description:

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

Treatment:

Device: Conventional arterial sheath