Cardiovascular Diseases, Coronary Artery Disease
Conditions
Keywords
distal radial artery, distal radial artery occlusion, cardiovascular intervention
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.
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.
Interventions
DEVICEGlideSheath Slender® and conventional arterial sheath
Using the GlideSheath Slender® with the outside diameter 2.46mm
DEVICEConventional arterial sheath
Placement of 6 French conventional Sheath (TERUMO, Introducer II )
Sponsors
Wujin People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
GlideSheath Slender® group Conventional Sheath group (TERUMO, Introducer II )
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of distal radial artery occlusion | 24 hours after the coronary angiography or intervention | The rate of distal radial artery occlusion is evaluated by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of radial artery occlusion | 24 hours after the coronary angiography or intervention | The rate of radial artery occlusion is evaluated by ultrasound |
| Pain during the placement of the sheath | 24 hours after the coronary angiography or intervention | 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 |
| Radial artery dissection | 24 hours after the coronary angiography or intervention | The incidence of dissection of the radial artery is evaluated by ultrasound |
| Time of hemostasis | 24 hours after the coronary angiography or intervention | The time from the compress to hemostasis |
| Haematoma | 24 hours after the coronary angiography or intervention | The incidence of haematoma is evaluated by Early Discharge After Transradial Stenting of Coronary Arteries Study criteria |
Countries
China
Contacts
Primary ContactGaojun Cai, Dr.
Outcome results
None listed